On May 11, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released over 90 pages of interim final regulations (the “Interim Final Regulations”) to revise the infection control requirements that long-term care facilities (Medicaid nursing facilities and Medicare skilled nursing facilities) and intermediate care facilities for individuals with intellectual disabilities (“ICFs-IID”) must meet to participate in the Medicare and Medicaid programs. Also on May 11, 2021, the Quality, Safety & Oversight Group at CMS issued a memorandum entitled “Interim Final Rule – COVID-19 Vaccine Immunization Requirements for Residents and Staff” (the “CMS Memo”) that announced the updated survey tools and new F-Tag to be used by surveyors to assess compliance with these new requirements. For this alert, “nursing homes” refers to skilled nursing facilities (often known as “SNFs”) for Medicare and nursing facilities (often known as “NFs”) for Medicaid.
Overview
The Interim Final Regulations strive to reduce the spread of COVID-19 infections by requiring education about COVID-19 vaccines for nursing home residents, ICF-IID clients and staff serving both populations, and by requiring that the vaccines, when available, be offered to all residents, ICF-IID clients and staff. It also requires nursing homes to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (“CDC”).
CMS considered extending the requirements included in this rule to other congregate living settings for which CMS has regulatory authority, including inpatient psychiatric hospitals and psychiatric residential treatment facilities, but did not include the requirements at this time as CMS believes it would not be feasible.
CMS detailed that many facilities across the country are educating staff, residents and resident representatives; participating in vaccine distribution programs; and voluntarily reporting vaccine administration. However, participation in these efforts is not universal and internal CDC data show that approximately 2,500 Medicare or Medicaid-certified LTC facilities (approximately 16 percent) did not participate in the CMS Pharmacy Partnership program.
The Interim Final Regulations establishes penalties for non-compliance, in order to require facilities to educate about and offer vaccination to residents and staff.
In order to help protect nursing homes from COVID-19, CMS calls for each nursing home to have a vaccination program that meets the educational and information needs of each resident, resident representative and staff member. The program should provide COVID-19 vaccines, when available, to all residents and staff who choose to receive them. Consistent vaccination reporting by nursing homes via the National Healthcare Safety Network (“NHSN”) will help to identify nursing homes that have potential issues with vaccine confidence or slow uptake among either residents or staff or both.
CMS is revising the nursing home requirements to specify that facilities must educate all residents and staff about COVID-19 vaccines, offer vaccination to all residents and staff and report certain data regarding vaccination and therapeutic treatments to CDC via NHSN.
Immunization education, delivery and reporting for influenza and pneumococcal vaccines are already a routine part of a nursing home’s infection control and prevention plans. CMS also requires nursing homes to offer education on influenza and pneumococcal vaccines and to give the resident or the resident representative the opportunity to accept or refuse the vaccine. Nursing homes must document a resident’s uptake or refusal of influenza and pneumococcal immunization in the resident’s medical record and report through a different electronic submission system, the Minimum Data Set (MDS). In order to standardize COVID-19 infection control and prevention in a nursing home, CMS requires these requirements for nursing homes to provide COVID-19 vaccine education, offer COVID-19 vaccination and report COVID-19 vaccinations for nursing home residents and staff.
Offer and Provide Vaccine to Nursing Home Residents and Staff
CMS is amending the requirements at § 483.80 to add a new paragraph (d)(3). CMS requires at new § 483.80(d)(3)(i) that nursing homes develop and implement policies and procedures to ensure that they offer residents and staff vaccination against COVID-19 when vaccine supplies are available. CMS is permitting, but not requiring nursing homes to provide the vaccine directly. Nursing homes may also provide it indirectly, such as through arrangement with a pharmacy partner or local health department.
Interim Final Regulations call for all residents and staff must be educated about the vaccine, CMS stated that in certain situations, for example, where an individual has already received a COVID-19 vaccine or has a known medical contraindication, the nursing home is not required to offer vaccination to that person.
COVID-19 Disease and Vaccine Education – Staff
Interim Final Regulations amend the requirements at §483.80 to add a new paragraph (d)(3)(ii) to require that nursing home staff are educated about vaccination against COVID-19. CMS is requiring that staff who work in the nursing home on a regular basis be educated about the benefits and risks and potential side effects of the COVID-19 vaccine. Staff education must cover the benefits of vaccination, which typically include reduced risk of COVID-19 illness and related serious COVID-19 outcomes, including hospitalization and death, the bolstered protection offered by completing a full series of multi-dose vaccines if used and other benefits identified as research continues.
For the purposes of COVID-19 vaccine education, offering and reporting, CMS considers nursing home staff to be those individuals who work in the facility on a regular (that is, at least once a week) basis. Note that this description of staff differs from that in § 483.80(h), established for the nursing home COVID-19 testing requirements. The Interim Final Regulations’ description of nursing home staff is limited to individuals working in the facility on a regular (at least weekly) basis, while the definition set out at § 483.80(h) includes workers who come into the nursing home infrequently, such as a plumber who may come in only a few times per year. CMS noted that facility-employed personnel, many facilities have services provided on-site, on a regular basis by individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals or volunteers. Any of these individuals who provide services on-site at least weekly would be included in “staff” who must be educated and offered the vaccine as it becomes available. Nursing homes are not required to educate and offer vaccination to individuals who provide services less frequently, but they may choose to extend such efforts to them.
COVID-19 Disease and Vaccine Education and Documentation – Residents and Resident Representatives
CMS amends the requirements at § 483.80 to add a new paragraph (d)(3)(iii) to require that nursing home residents or resident representatives are educated about vaccination against COVID-19. Explaining the risks and possible side effects and benefits of any treatments to a resident or their representative in a way that they can understand is the standard of care, and a patient right as specified at § 483.10(c)(5). In nursing homes, consent or assent for vaccination should be obtained from residents and/or their representatives as appropriate and documented in the resident’s medical record. The residents or their representatives have the right to decline the vaccine, based on the resident’s rights requirement at § 483.10(c)(5). Resident representatives must be included as a component of the nursing home’s vaccine education plan, as the resident representatives may be called upon for consent and/or may be asked to assist in promoting vaccine uptake of the resident, as appropriate.
In addition to the topics addressed above for education of nursing home staff, education of residents and resident representatives should cover that, at this time while the Federal Government is purchasing all COVID-19 vaccines in the United States for administration through the CDC COVID-19 Vaccination Program, all nursing home residents are able to receive the vaccine without any copays or out-of-pocket costs. Education for residents and representatives must also provide the opportunity for follow-up questions and be conducted in a manner that is reasonably understood by the resident and the representatives.
The CMS Memo provides that the resident’s medical record must include documentation that indicates, at a minimum, 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 representative) either accepted and received the COVID-19 vaccine or did not receive the vaccine due to medical contraindications, prior vaccination or refusal.
Nursing Home Data Reporting
CMS is amending the requirements at § 483.80(g) to require that nursing homes report to NHSN, on a weekly basis, the COVID-19 vaccination status and related data elements of all residents and staff. The data to be reported each week will be cumulative, that is, data on all residents and staff, including total numbers and those who have received the vaccine, as well as additional data elements. Nursing homes must also report any COVID-19 therapeutics administered to residents. CDC has currently defined “therapeutics” for the purposes of the NHSN as a “treatment, therapy, or drug” and stated that monoclonal antibodies are examples of COVID-19 antibody-based therapeutics used to help the immune system recognize and respond more effectively to COVID-19.
The information reported to CDC in accordance with § 483.80(g) will be shared with CMS and CMS will retain and publicly report this information to support protecting the health and safety of residents, staff and the general public. The stated goal in mandating reporting of COVID-19 vaccines and therapeutics to NHSN is to monitor broader community vaccine uptake and allow CDC to identify and alert CMS to nursing homes that may need vaccine education and administration support.
Survey Guidance
The CMS Memo details the creation of the new F-Tag 887. The CMS Memo set out that to determine compliance with §483.80(d)(3), surveyors will request a facility point of contact to provide information on how residents and staff are educated about and offered the COVID-19 vaccine, including samples of educational materials. Surveyors will also request a list of residents and staff and their COVID-19 vaccination status from which they will select a sample of residents and staff to review records and conduct interviews to confirm they were educated on and offered the COVID-19 vaccine in accordance with the new requirements.
The Interim Final Regulation provided that surveyors and state agency surveyors will use the vaccination data in conjunction with the reported data that includes COVID-19 cases, resident deaths, staff shortages, personal protective equipment supplies and testing. This combination of reported data is used by surveyors to determine individual facilities that need to have focused infection control surveys.
CMS will update the “Infection Prevention, Control & Immunizations” Facility Task to include the new requirement at F-887 for educating residents or resident representatives and staff and offering the COVID-19 vaccine. CMS will also update associated survey documents.
Effective
The Interim Final Regulation is scheduled to go into effect on May 21, 2021, ten days from its filing for publication for inspection in the Federal Register. Publication is set for May 13, 2021.
Practical Takeaways
Nursing homes should:
- Develop and prepare the policies and procedures to carry out these new mandates.
- Create education materials for staff, residents and resident representatives of the vaccine.
- Adopt procedures and practices for documenting their actions and education.
- Develop systems and back-ups for the reporting requirements.
If you have questions or would like additional information about this topic, please contact:
- Sean Fahey at (317) 977-1472 or sfahey@wp.hallrender.com;
- Todd Selby at (317) 977-1440 or tselby@wp.hallrender.com;
- Brian Jent at (317) 977-1402 or bjent@wp.hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer an individual’s questions that may constitute legal advice.
