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DEPARTMENT OF HEALTH AND of the following three ways (please territories. The virus has been named HUMAN SERVICES choose only one of the ways listed): ‘‘severe acute respiratory syndrome 1. Electronically. You may submit coronavirus 2’’ (SARS–CoV–2), and the Centers for Medicare & Medicaid electronic comments on this regulation disease it causes has been named Services to http://www.regulations.gov. Follow ‘‘coronavirus disease 2019’’ (COVID– the ‘‘Submit a comment’’ instructions. 19). On January 30, 2020, the 42 CFR Part 483 2. By regular mail. You may mail International Health Regulations written comments to the following Emergency Committee of the World [CMS–3414–IFC] address ONLY: Centers for Medicare & Health Organization (WHO) declared Medicaid Services, Department of the outbreak a ‘‘Public Health RIN 0938–AU57 Health and Human Services, Attention: Emergency of International Concern.’’ Medicare and Medicaid Programs; CMS–3414–IFC, P.O. Box 8010, On January 31, 2020, pursuant to COVID–19 Vaccine Requirements for Baltimore, MD 21244–1850. section 319 of the Public Health Service Long-Term Care (LTC) Facilities and Please allow sufficient time for mailed Act (PHSA) (42 U.S.C. 247d), the Intermediate Care Facilities for comments to be received before the Secretary of the Department of Health Individuals With Intellectual close of the comment period. and Human Services (Secretary) Disabilities (ICFs–IID) Residents, 3. By express or overnight mail. You determined that a public health Clients, and Staff may send written comments to the emergency (PHE) exists for the United following address ONLY: Centers for States to aid the nation’s health care AGENCY: Centers for Medicare & Medicare & Medicaid Services, community in responding to COVID–19 Medicaid Services (CMS), Department Department of Health and Human (hereafter referred to as the PHE for of Health and Human Services (HHS). Services, Attention: CMS–3414–IFC, COVID–19). On March 11, 2020, the ACTION: Interim final rule with comment Mail Stop C4–26–05, 7500 Security WHO publicly declared COVID–19 a period. Boulevard, Baltimore, MD 21244–1850. pandemic. On March 13, 2020, the For information on viewing public President of the United States declared SUMMARY: This interim final rule with comments, see the beginning of the the COVID–19 pandemic a national comment period (IFC) revises the SUPPLEMENTARY INFORMATION section. emergency. The January 31, 2020 infection control requirements that long- FOR FURTHER INFORMATION CONTACT: determination that a PHE for COVID–19 term care (LTC) facilities (Medicaid Diane Corning, (410) 786–8486, Lauren exists and has existed since January 27, nursing facilities and Medicare skilled Oviatt, (410) 786–4683, Kim Roche, 2020, lasted for 90 days, and was nursing facilities, also collectively (410) 786–3524, or Kristin Shifflett, renewed on April 21, 2020; July 23, known as ‘‘nursing homes’’) and (410) 786–4133, for all rule related 2020; October 2, 2020; and January 7, intermediate care facilities for issues. 2021. Pursuant to section 319 of the individuals with intellectual disabilities PHSA, the determination that a PHE SUPPLEMENTARY INFORMATION: Inspection (ICFs–IID) must meet to participate in continues to exist may be renewed at of Public Comments: All comments the Medicare and Medicaid programs. the end of each 90-day period.1 Data received before the close of the This IFC aims to reduce the spread of from the Centers for Disease Control and comment period are available for SARS–CoV–2 infections, the virus that Prevention (CDC) and other sources viewing by the public, including any causes COVID–19, by requiring have determined that some people are at personally identifiable or confidential education about COVID–19 vaccines for higher risk of severe illness from business information that is included in LTC facility residents, ICF–IID clients, COVID–19.2 a comment. We post all comments and staff serving both populations, and Individuals residing in congregate received before the close of the by requiring that such vaccines, when settings, regardless of health or medical comment period on the following available, be offered to all residents, conditions, are at greater risk of website as soon as possible after they clients, and staff. It also requires LTC acquiring infections, and many have been received: http:// facilities to report COVID–19 residents and clients of long-term care www.regulations.gov. Follow the search vaccination status of residents and staff (LTC) facilities and Intermediate Care instructions on that website to view to the Centers for Disease Control and Facilities for Individuals with public comments. CMS will not post on Prevention (CDC). These requirements Intellectual Disabilities (ICFs–IID) face Regulations.gov public comments that are necessary to help protect the health higher risk of severe illness due to age, make threats to individuals or and safety of ICF–IID clients and LTC disability, or underlying health institutions or suggest that the facility residents. In addition, the rule conditions. Nursing home residents are individual will take actions to harm the solicits public comments on the less than 1 percent of the American individual. CMS continues to encourage potential application of these or other population, but have historically individuals not to submit duplicative requirements to other congregate living accounted for over one-third of all comments. We will post acceptable settings over which CMS has regulatory COVID–19 deaths.3 comments from multiple unique or other oversight authority. commenters even if the content is 1 DATES: https://www.phe.gov/emergency/events/ These regulations are effective identical or nearly identical to other COVID19/Pages/2019-Public-Health-and-Medical- on May 21, 2021. comments. Emergency-Declarations-and-Waivers.aspx. Comment date: To be assured 2 Centers for Disease Control and Prevention. consideration, comments must be I. Background (2020). People at Increased Risk. Retrieved from: received at one of the addresses https://www.cdc.gov/coronavirus/2019-ncov/need- Currently, the United States (U.S.) is extra-precautions/index.html. provided below, no later than 5 p.m. on responding to a public health 3 See The Long-Term Care COVID Tracker at July 12, 2021. emergency of respiratory disease caused https://covidtracking.com/nursing-homes-long- ADDRESSES: In commenting, please refer by a novel coronavirus that has now term-care-facilities, and the KFF State COVID–19 Data and Policy Actions at https://www.kff.org/ to file code CMS–3414–IFC. been detected in more than 190 coronavirus-covid-19/issue-brief/state-covid-19- Comments, including mass comment countries internationally, all 50 States, data-and-policy-actions/#longtermcare. These data submissions, must be submitted in one the District of Columbia, and all U.S. may understate the problem because some states do

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A. COVID–19 in Congregate Living comment on the feasibility of homes or communities rather than Settings implementing vaccination policies for institutions or other isolated settings. Since there is no single official other Medicare/Medicaid participating These programs serve a diverse definition of congregate living settings, shared residences in which one or more population, including people with also referred to as residential people reside such as but not limited to intellectual or developmental habilitation settings, for purposes of this the following: Psychiatric residential disabilities, physical disabilities, mental discussion we describe them as shared treatment facilities (PRTFs), psychiatric illness, and HIV/AIDS. Shared living residences of any size that provide hospitals, forensic hospitals, adult foster arrangements within, and the sharing of services to clients and residents. People care homes (AFC homes), group homes, staff across these and other settings can living and working in these living assisted living facilities (ALFs), lead to increased risk of COVID–19 situations may have challenges with supervised apartments, and inpatient outbreaks. In addition, individuals social distancing and other mitigation hospice facilities. living in these settings often have measures, like mask use and We considered extending the multiple chronic conditions that can handwashing, that help to prevent the requirements included in this rule to increase the risk of severe disease and spread of SARS–CoV–2. Residents, other congregate living settings for complicate treatment of, and recovery clients, and staff typically may gather which we have regulatory authority, from, COVID–19. This makes the together closely for social, leisure, and including inpatient psychiatric vaccination of clients and staff in these recreational activities, shared dining, hospitals (which are subject to the congregate living settings a critical and/or use of shared equipment, such as majority of Hospital Conditions of component of a jurisdiction’s vaccine kitchen appliances, laundry facilities, Participation, including § 482.42, implementation plan. vestibules, stairwells, and elevators. ‘‘Infection Control’’) and PRTFs, but In an effort to facilitate a Residents in some congregate living have not included such requirements in comprehensive vaccine administration facilities may also receive care from day this interim final rule because we strategy, we encourage providers who habilitation facilities such as adult day believe it would not be feasible at this manage Medicare and/or Medicaid health centers. Some congregate living time. Individuals in psychiatric participating congregate living settings residents require close assistance and hospitals, for example, may only be in- (such as psychiatric hospitals or PRTFs) support from facility staff, which further patients for short periods, making or settings in which Medicaid-funded reduces their ability to maintain appropriate provision of a two-dose HCBSs are provided (ALFs, group physical distance. On March 2, 2021, vaccine series challenging, although a homes, shared living/host home CDC issued Interim Considerations for one dose vaccine product is also now settings, supported living settings, and Phased Implementation of COVID–19 authorized. Because we are not able to others) to voluntarily engage in the Vaccination and Sub-Prioritization guarantee sufficient availability of single provision of the culturally and Among Recommended Populations, dose COVID–19 vaccines at this time, or linguistically appropriate and accessible which notes that increased rates of in the near future, to meet the potential education and vaccine-offering activities transmission have been observed in demands of facilities with relatively described in this IFC. Vaccine short stays, we are focusing on facilities availability may vary based on location, these settings, and that jurisdictions that have longer term relationships with and vaccination and medical staff may choose to prioritize vaccination of patients and are thus also able to authorized to administer the vaccination persons living in congregate settings administer all doses of and track multi- may not be readily available onsite at based on local, state, tribal, or territorial dose vaccines. PRTFs only serve many congregate living or residential epidemiology. CDC further notes that children and youth under the age of 21 care settings. Therefore, facilities should congregate living facilities may choose years, and there is not yet a COVID–19 consult state Medicaid agencies and to vaccinate residents and clients at the vaccine authorized or licensed for state and local health departments to same time as staff, because of shared people younger than the age of 16 years understand the range of options for how increased risk of disease.4 in the United States. We are seeking vaccine provision can be made available This rule establishes requirements for public comment on the feasibility of to residents, clients, and staff. In LTC facilities and ICFs–IID; however, adding appropriate COVID–19 addition, we encourage state Medicaid we recognize that individuals in all vaccination requirements for residents, agencies, in partnership with public congregate living settings may have had clients, and staff of all congregate living health agencies, to collaborate with similar experiences and outcomes facilities where CMS has regulatory congregate living settings to ensure their during the PHE as individuals living or authority and pays for some portion of involvement in vaccine distribution staying in institutional settings. We the care and services provided. strategies, and to facilitate vaccination acknowledge that many congregate Specifically, we are interested in of beneficiaries and staff as efficiently as living facilities may not fall into any comments on potential barriers facilities possible. Lastly, we request public single category or may be classified may face in meeting the requirements, comment on challenges congregate differently depending on the state in such as staffing issues or characteristics living settings might encounter in which they are located. We further note of the resident or client population, and complying with these IFC provisions, that some other congregate living potential unintended consequences. We including in reporting vaccine settings, such as dormitories, prisons, welcome suggestions on how the information to CDC’s National and shelters for people experiencing regulations should be revised to ensure Healthcare Safety Network (NHSN). homelessness, have also faced higher that congregate living within our We acknowledge the diversity and risks of disease transmission, and these regulatory authority are able to reduce complexity of the needs of congregate settings are not within our scope of the spread of SARS–CoV–2 infections. living facilities. We understand that authority. CMS is seeking public While congregate living settings are factors such as coordination of care with also often part of a state’s and home and day habilitation sites, adult day health not count as nursing home deaths persons infected community-based services (HCBS) providers, hospice providers, and other in nursing homes but transferred to hospitals and recorded as hospital deaths. infrastructure. HCBS is an umbrella entities, and also high rates of staff 4 https://www.cdc.gov/vaccines/covid-19/phased- term for long term services and supports turnover may impede the implementation.html#congregate-living-settings. that are provided to people in their own implementation of a COVID–19

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vaccination program. To enhance our can further support safety and reduce 2021). Many states have either closed a future efforts to support reasonable and the risk of infection moving forward. significant number of these facilities effective COVID–19 vaccination This interim final rule with comment is completely or downsized them through programs in congregate living facilities, one step in the broad effort to support ‘‘rebalancing’’ efforts,7 and the impetus we seek public comment on a number those individuals at higher risk, in part of the Supreme Court’s Olmstead of issues, including the following: because of living or working decision.8 Many ICF–IID clients have • Are there state or local vaccine arrangements. Comments from multiple chronic conditions and policies, for COVID–19 vaccines or congregate living providers, advocacy psychiatric conditions in addition to otherwise, already in place for groups, professional organizations, their intellectual disability, which can congregate living facilities and related HCBS providers (including day impact a client’s understanding or agencies, such as adult day health habilitation and adult day health acceptance of the need for vaccination. programs, either in the licensing or providers), residents, clients, staff, All must financially qualify for certification requirements or elsewhere? family members, paid and unpaid Medicaid assistance. While national How have they been helpful to your caregivers, and other stakeholders will data about ICF–IID clients is limited, we facility or program? help inform future CMS actions. take an example from Florida, almost • Does your program or facility have one quarter (23 percent) require 24-hour vaccine policies? How are they B. ICFs–IID and COVID–19 nursing services and a medical care plan structured and what challenges have ICFs–IID, residential facilities that in addition to their services plans.9 Data you faced with regard to provide services for people with from a single state is not nationally implementation? Do policies include disabilities, vary in size. In such representative and thus we are unable to residents, clients and staff? settings, several factors may facilitate generalize, but it is illustrative and • If a vaccine policy applied to both the introduction and spread of SARS– consistent with other states’ trends. shared living and day programs for CoV–2, the virus that causes COVID–19. These co-occurring conditions may adult day health or day habilitation, for Staff working in these facilities often increase the risks of infectious diseases example, who or what entity should work across facility types (that is, for clients of ICFs–IID above the risk have the responsibility for ensuring that nursing home, group home, different levels experienced by the general all residents and staff have access to congregate settings within the population. Clients and residents often COVID–19 vaccination? Is there existing employer’s purview), and for different live in close quarters. Some may not or capacity for case management for providers, which may contribute to understand the dangers of the virus, or individuals engaging with both disease transmission. Other factors be able to independently comply with residential care and programs that occur impacting virus transmission in these mitigation measures. Those who need outside the residential setting? settings might include: Clients who are help with activities of daily living • What barriers exist to the employed outside the congregate living cannot maintain their distance from implementation of a COVID–19 setting; clients who require close staff and caregivers. During the PHE, vaccination policy for residents and contact with staff or direct service some facilities have struggled to retain staff of congregate living facilities? providers; clients who have difficulty staff and, as noted above, some staff • How can equitable access to understanding information or practicing working in these facilities may also have COVID–19 vaccine be ensured for preventive measures; and clients in more than one job that puts them at residents and clients of congregate close contact with each other in shared higher risk.10 Currently, the Conditions living facilities and related agencies? living or working spaces. ICF–IID clients of Participation: ‘‘Health Care Services’’ • Are congregate living facilities with certain underlying medical or at § 483.460(a)(3), require ICFs–IID to currently facing challenges in tracking psychiatric conditions may be at provide or obtain preventive and staff vaccination status? If so, explain. increased risk of serious illness from general medical care as well as annual • Has your State or county included COVID–19.5 physical examinations of each client residential and adult day health or day There are currently 5,768 Medicare- that at a minimum include the habilitation staff on the vaccine-eligible and/or Medicaid-certified ICFs–IID, and following: Evaluation of vision and list as health care providers? What other all 50 States have at least one ICF–IID. hearing; immunizations; routine impediments do staff face in getting As of April 2021, 4,661 of the 5,770 are screening laboratory examinations as access to vaccines? small (1 to 8 beds) in size, but there are determined necessary by the physician, Where such data are available, we are 1,107 that are larger (14 or more beds) special studies when needed; and requesting respondents include data facilities. These facilities serve over tuberculosis control, appropriate to the indicating: 64,812 individuals with intellectual facility’s population. While the existing • The rate of admission to congregate disabilities and other related conditions. requirements should ensure that ICFs– living facilities. IID provide clients with a COVID–19 • ICFs–IIDs were originally conceived as The average length of stay for large institutions, but caregivers and vaccine, we note that it does not address residents of congregate living facilities. vaccine education. Further, we believe • policymakers quickly recognized the The variety and prevalence of potential benefits of greater community that the unprecedented risks associated comorbidities in individuals served that integration, spawning the growth in the with the COVID–19 PHE warrant direct may increase their risk of severe illness early 1980s of community ICFs–IID with attention. ICFs–IID have not historically from COVID–19. between four and 15 beds.6 The number been required to participate in national • The rate of employee sharing of individuals residing in large public reporting programs to the extent that between congregate living facilities and ICFs–IID has decreased steadily over the rate of employee turnover. 7 time (from 55,000 total residents in 1997 https://www.medicaid.gov/sites/default/files/ We acknowledge the lengths that 2019-12/mfp-rtc.pdf. congregate living and HCBS providers to approximately 16,000 as of April 8 https://www.ada.gov/olmstead/S. have gone to keep their residents, 9 http://www.floridaarf.org/assets/Files/ICF- 5 https://www.cdc.gov/coronavirus/2019-ncov/ IID%20Info%20Center/ICFHandoutonwebsite2- clients, and staff as safe as possible need-extra-precautions/index.html. 14.pdf. during the COVID–19 PHE, and request 6 https://aspe.hhs.gov/system/files/pdf/76956/ 10 https://www.medicaid.gov/medicaid/long-term- their input on ways that CMS and HHS MFIS.pdf. services-supports/workforce-initiative/index.html.

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other health care facilities have. Despite that each client receive a continuous Patient Protection and Affordable Care the limited data available regarding active treatment program, which Act; Additional Policy and Regulatory COVID–19 cases or outbreak in ICFs– includes consistent implementation of a Revisions in Response to the COVID–19 IID, we recognize the unique concerns program of specialized and generic Public Health Emergency’’ interim final for these facilities and their clients and training, treatment, health services and rule with comment, which appeared in staff. We note that CDC has established related services. CMS is currently the September 2, 2020 Federal Register COVID–19 infection, prevention, and waiving those components of (85 FR 54820) with an effective date of control guidance specific to group beneficiaries’ active treatment programs September 2, 2020 (hereafter referred to homes for individuals with disabilities, and training that would violate current as the ‘‘September 2nd COVID–19 as noted earlier, recently released an state and local requirements for social IFC’’).13 The September 2nd COVID–19 updated guidance on vaccination and distancing, staying at home, and IFC strengthened CMS’ ability to enforce sub-prioritization that discusses this traveling for essential services only. compliance with LTC reporting group.11 C. LTC Facilities and COVID–19 requirements and established a new CMS and other Federal agencies took requirement for LTC facilities to test many actions and exercised regulatory Long-term care facilities, a category facility residents and staff for COVID– flexibilities to help health care that includes Medicare SNFs and 19. We received 171 public comments providers contain the spread of SARS– Medicaid nursing facilities (NFs), must in response to the September 2nd CoV–2. When the President declares a meet the consolidated Medicare and COVID–19 IFC, of which 113 addressed national emergency under the National Medicaid requirements for participation the requirement for COVID–19 testing of Emergencies Act or an emergency or (requirements) for LTC facilities (42 CFR LTC facility residents and staff set forth disaster under the Stafford Act, CMS is part 483, subpart B) that were first at § 483.80(h). empowered to take proactive steps by published in the Federal Register on Health care inequities faced by the waiving certain CMS regulations, as February 2, 1989 (54 FR 5316). These general population, discussed further in authorized under section 1135 of the regulations have been revised and Section I.D. of this rule, are also seen Social Security Act (‘‘1135 waivers’’). added to since that time, principally as within LTC facilities. Despite the CMS may also waive requirements set a result of legislation or a need to increased use of nursing homes by out under section 1812(f) of the Social address specific issues. The minority residents, nursing home care Security Act (the Act) applicable to requirements were comprehensively remains highly segregated. Compared to reviewed and updated in October 2016 skilled nursing facilities (SNFs) under Whites, racial/ethnic minorities tend to (81 FR 68688), including a Medicare (‘‘1812(f) waivers’’). The 1135 be cared for in facilities with limited comprehensive update to the waivers and 1812(f) waivers allowed us clinical and financial resources, low requirements for infection prevention to rapidly expand efforts to help control nurse staffing levels, and a relatively and control. the spread of SARS–CoV–2. high number of care deficiency Currently, CMS has waived the Since the onset of the PHE, we have citations.14 Nursing homes with following regulations for ICF–IIDs, with revised the requirements for LTC relatively high shares of Black or a retroactive effective date of March 1, facilities through two interim final rules Hispanic residents were more likely to 2020, and continuing through the end of with comment periods (IFCs) to report at least one COVID–19 death than the public health emergency declaration establish reporting and testing nursing homes with lower shares of and any extensions, unless they are requirements specific to the mitigation Black or Hispanic residents.15 terminated earlier. CMS has waived the of the current pandemic. The first IFC requirements at § 483.430(c)(4), which was the ‘‘Medicare and Medicaid D. Current COVID–19 Vaccination requires the facility to provide sufficient Programs, Basic Health Program, and Activities in LTC Facilities and ICFs–IID Exchanges; Additional Policy and Direct Support Staff (DSS) so that Direct Because of the expedient Regulatory Revisions in Response to the Care Staff (DCS) are not required to development of COVID–19 vaccines and COVID–19 Public Health Emergency perform support services that interfere their authorization for emergency use by and Delay of Certain Reporting with direct client care. We also waived the U.S. Food and Drug Administration Requirements for the Skilled Nursing the requirements at § 483.420(a)(11) (FDA), the requirements for LTC Facility Quality Reporting Program’’ which requires clients have the facilities and Conditions of Participation interim final rule with comment, which opportunity to participate in social, (CoPs) for ICFs–IID do not currently appeared in the May 8, 2020 Federal religious, and community group address issues of resident and staff Register (85 FR 27550) with an effective activities. Finally, we also waived, in vaccination education, or reporting date of May 8, 2020 (hereafter referred part, the requirements at § 483.430(e)(1) COVID–19 vaccinations or therapeutic to as the ‘‘May 8th COVID–19 IFC’’).12 related to routine staff training programs treatments to CDC. Nonetheless, many unrelated to the public health The May 8th COVID–19 IFC established facilities across the country are emergency. CMS has not waived requirements for LTC facilities to report educating staff, residents, and resident § 483.430(e)(2) through (4), which information related to COVID–19 cases representatives; participating in vaccine requires focusing on the clients’ among facility residents and staff. We distribution programs; and voluntarily developmental, behavioral, and health received 299 public comments in reporting vaccine administration. needs and being able to demonstrate response to the May 8th COVID–19 IFC. However, participation in these efforts skills related to interventions for About 161, or over one-half of those is not universal and we are concerned challenging behaviors and comments, addressed the requirement that many groups at higher risk of implementing individual plans. for COVID–19 reporting for LTC infection, specifically residents and CMS recognizes that during the public facilities set forth at § 483.80(g). The clients of LTC facilities and ICFs–IID, health emergency ‘‘active treatment’’ second IFC was the ‘‘Medicare and may need to be modified. The Medicaid Programs, Clinical Laboratory 13 https://www.federalregister.gov/documents/ requirements at § 483.440(a)(1) require Improvement Amendments (CLIA), and search?conditions%5Bterm%5D=85FR54820#. 14 https://www.healthaffairs.org/doi/full/10.1377/ 11 https://www.cdc.gov/coronavirus/2019-ncov/ 12 https://www.federalregister.gov/documents/ hlthaff.2015.0094. community/group-homes.html. search?conditions%5Bterm%5D=85FR27550#. 15 https://www.kff.org/070b9a9/.

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are not able to access COVID–19 that may have been experienced by LTC Historical patterns of inequity in health vaccination. While all nursing homes facility residents and ICF–IID clients. care may persist despite the emphasis of across the U.S. (whether or not certified This IFC aims to ensure that all LTC public health officials on the need for as a Medicare or Medicaid provider) facility residents, ICF–IID clients, and equitable access to and utilization of were invited to participate in the the staff who care for them, are provided preventive measures. Inequities have COVID–19 vaccination Pharmacy with ongoing access to vaccination persisted through the COVID–19 PHE, Partnerships (discussed further in against COVID–19. The accountable with racial and ethnic minorities section II.A.1. of this rule), internal CDC entities responsible for the care of continuing to have higher rates of data show that approximately 2,500 residents and clients of LTC facilities infection and mortality.20 Ensuring that Medicare or Medicaid-certified LTC and ICFs–IID must proactively pursue all residents, clients, and staff of LTC facilities (approximately 16 percent) did access to COVID–19 vaccination due to facilities and ICFs–IID have access to not participate in the Pharmacy a unique set of challenges that generally COVID–19 vaccinations seeks to address Partnership program. prevent these residents and clients from some of those inequities and provide Given the congregate living models of independently accessing the vaccine. timely protection for these individuals. LTC facilities and ICFs–IID, and the These challenges create potential Ensuring that all LTC facility higher risk nature of their residents and disparities in vaccine access for those residents, ICF–IID clients, and the staff clients due to age, comorbidities, and residing in LTC facilities and ICFs–IID. who care for them are provided with disabilities, people living and working CDC has recommended states place LTC ongoing opportunities to receive in these facilities are at high risk of facility residents and health care vaccination against COVID–19 is critical COVID–19 outbreaks, with residents personnel into Phase 1a.17 Despite their to ensuring that populations at higher and clients seeing higher rates of inclusion in most states’ tier 1 vaccine risk of infection continue to be incidence, morbidity, and mortality priority category, it is CMS’s prioritized, and receive timely than the general population. Data understanding that very few individuals preventive care during the COVID–19 submitted to CDC’s NHSN and posted who are residents of LTC facilities are PHE. This rule establishes penalties for on data.cms.gov for the week ending likely able to independently schedule or non-compliance, in order to require April 11, 2021 shows cumulative totals travel to public offsite vaccination facilities to educate about and offer of 647,754 LTC resident COVID–19 opportunities. People reside in LTC vaccination to residents and staff. confirmed cases and 131,926 LTC facilities and ICFs–IID because they Based on the current rate of incidence resident COVID–19 confirmed deaths. need ongoing support for medical, of COVID–19 disease and deaths among Also, there have been at least 569,502 cognitive, behavioral, and/or functional LTC residents, we believe more action total LTC staff COVID–19 confirmed reasons. Because of these issues, they can be taken to help staff and residents cases and 1,888 total LTC staff COVID– may be less capable of self-care, avoid contracting SARS–CoV–2. LTC 19 confirmed deaths, on a cumulative including arranging for preventive facility staff are also at risk of basis. While we do not currently have health care. Independent scheduling transmitting SARS–CoV–2 to residents, data regarding the incidence of COVID– and traveling off-site may be especially experiencing illness or death as a result 19 cases in ICFs–IID, we believe that challenging for people with low health of COVID–19 themselves, and these facilities may have also literacy, intellectual and developmental transmitting it to their families, friends, experienced significant rates of disabilities, dementia including unpaid caregivers and the general infection and that these data are likely Alzheimer’s disease, visual or hearing public. Asymptomatic people with an underestimate. A FAIR Health study impairments, or severe physical SARS–CoV–2 may move in and out of examined the relationship between disability. This situation is particularly the LTC facility and the community, preexisting comorbidities of COVID–19 concerning because people with putting residents and staff at risk of and mortality in privately insured intellectual or developmental infection. Routine testing of LTC individuals as reported in a white disabilities are at a disproportionate risk residents and staff, along with visitation paper, Risk Factors for COVID–19 of contracting COVID–19.18 restrictions, personal protective Mortality among Privately Insured Similarly, there are large equipment (PPE) usage, social Patients: A Claims Data Analysis.16 The subpopulations of Americans who distancing, and vaccination for residents paper states that there are several experience inequities on a regular basis and staff are all part of CDC’s Interim possible reasons for the high COVID–19 in accessing quality health care beyond Infection Prevention and Control mortality risk in people with COVID–19 vaccination. Certain groups Recommendations to Prevent SARS– developmental disorders and experience health and health care CoV–2 Spread in Nursing Homes.21 intellectual disabilities. These include inequity, such as racial and ethnic COVID–19 vaccines are a crucial tool for greater prevalence of comorbid chronic minorities; members of religious slowing the spread of disease and death conditions. We seek information from minorities; lesbian, gay, bisexual, among both residents, staff, and the the public regarding the epidemiologic transgender, and queer (LGBTQ+) general public. Based on the Food and burden of COVID–19 on ICFs–IIDs, persons; people with disabilities; people Drug Administration’s (FDA) review, reporting COVID–19 data by ICFs–IID, living in rural areas; and others. evaluation of the data, and their existing barriers to reporting, and ways The COVID–19 pandemic has decision to authorize three vaccines for to enhance and encourage voluntary exacerbated these health care inequities emergency use, we recognize that these reporting of COVID–19-related data to as the country faces a convergence of vaccines meet FDA’s standards for an CDC’s NHSN reporting module. economic, health, and climate crises.19 emergency use authorization (EUA) for We also request comment on safety and effectiveness to prevent inequities in COVID–19 preventive care 17 https://www.cdc.gov/coronavirus/2019-ncov/ vaccines/recommendations.html. underserved-communities-through-the-federal- 16 https://s3.amazonaws.com/media2.fairhealth. 18 https://www.cdc.gov/coronavirus/2019-ncov/ government/. org/whitepaper/asset/Risk%20Factors%20for need-extra-precautions/people-with-developmental- 20 https://tcf.org/content/commentary/even- %20COVID-19%20Mortality%20among%20 disabilities.html. nursing-homes-covid-19-racial-disparities-persist/ Privately%20Insured%20Patients%20-%20A%20 19 https://www.whitehouse.gov/briefing-room/ ?agreed=1. Claims%20Data%20Analysis%20-%20A%20FAIR presidential-actions/2021/01/20/executive-order- 21 https://www.cdc.gov/coronavirus/2019-ncov/ %20Health%20White%20Paper.pdf. advancing-racial-equity-and-support-for- hcp/long-term-care.html.

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COVID–19 disease and related serious of COVID–19 vaccination outweigh the participation is not traced to or shared outcomes, including hospitalization and risks or possible side effects.26 with specific health care providers. death. The combination of vaccination, The COVID–19 vaccines currently F. FDA & Emergency Use Authorization universal source control (wearing authorized for use in the United States (EUA) of COVID–19 Vaccines masks), social distancing, and hand- require either a single dose or a series The FDA provides scientific and washing offers further protection from of two doses given three to four weeks COVID–19.22 regulatory advice to vaccine developers apart. Every person who receives a and undertakes a rigorous evaluation of Similar to LTC facilities, due to the COVID–19 vaccine receives a the scientific information through all recent development and authorization vaccination record card noting which phases of clinical trials; such evaluation of COVID–19 vaccines, the conditions of vaccine and the dose received. Vaccine continues after a vaccine has been participation for ICF–IIDs do not materials specific to each vaccine are licensed by FDA or authorized for currently address issues of client and located on CDC and FDA websites. CDC emergency use. staff vaccine education. Many CMS- has posted a LTC facility toolkit CMS recognizes the gravity of the certified ICFs–IID across the country are ‘‘Preparing for COVID–19 Vaccination at current public health emergency and the educating staff, clients, and client your Facility’’ at https://www.cdc.gov/ importance of facilitating availability of representatives, and attempting to vaccines/covid-19/toolkits/long-term- vaccines to prevent COVID–19. An EUA participate in vaccination programs. care/. This toolkit provides LTC (authorized under section 564 of the However, participation in these efforts administrators and clinical leadership Federal Food, Drug, and Cosmetic Act) is not universal, and we are concerned with information and resources to help is a mechanism to facilitate the that many individuals are not receiving build vaccine confidence among availability and use of medical these important preventive care residents, clients, and staff. CDC has countermeasures, including vaccines, services. also posted an ICF–IID toolkit ‘‘Toolkit during public health emergencies, such for people with Disabilities’’ at https:// as the current COVID–19 pandemic. The E. COVID–19 PHE and Vaccine www.cdc.gov/coronavirus/2019-ncov/ FDA may authorize certain unapproved Development communication/toolkits/people-with- medical products or unapproved uses of Ensuring that LTC residents, ICF–IID disabilities.html. This toolkit provides approved medical products to be used clients, and staff have the opportunity to guidance and tools to help people with in an emergency to diagnose, treat, or receive COVID–19 vaccinations will disabilities and paid and unpaid prevent serious or life-threatening help save lives and prevent serious caregivers make decisions, help protect diseases or conditions caused by threat illness and death. On December 1, 2020, their health, and communicate with agents when certain criteria are met, their communities. including there are no adequate, the Advisory Committee in 28 Immunization Practices (ACIP) met and approved, and available alternatives. While we are not requiring VAERS is a safety and monitoring provided recommendations; CDC participation, we encourage individual system that can be used by anyone to adopted ACIP’s recommendation: That residents, clients, and staff who use report adverse events with vaccines. health care personnel and long-term smartphones to use CDC’s new While the COVID–19 vaccines are being care facility residents be offered smartphone-based tool called v-safe used under an EUA, vaccination COVID–19 vaccination first (Phase After Vaccination Health Checker (v- 23 providers, manufacturers, and EUA 1a). safe) to self-report on one’s health after sponsors must, in accordance with the All COVID–19 vaccines currently receiving a COVID–19 vaccine. V-safe is National Childhood Vaccine Injury Act authorized for use in the United States a new program that differs from the (NCVIA) of 1986 (42 U.S.C. 300aa–1 to were tested in clinical trials involving Vaccine Adverse Event Reporting 300aa–34), report select adverse events tens of thousands of people and met System (VAERS), which we discuss in to VAERS (that is, serious adverse FDA’s standards for safety, the section I.F. of this rule. Individuals events, cases of multisystem effectiveness, and manufacturing quality may report adverse reactions to a inflammatory syndrome (MIS), and needed to support emergency use COVID–19 vaccine to either program. COVID–19 cases that result in authorization. The clinical trials Enrollment in v-safe allows individuals hospitalization or death).29 Providers included participants of different races, to directly report to CDC any problems also must adhere to any revised safety ethnicities, and ages, including adults or adverse reactions after receiving the reporting requirements. FDA’s EUA over the age of 65.24 The most common vaccine. When an individual receives website includes letters of authorization side effects following vaccination are the vaccine, they should also receive a and fact sheets and these should be dependent on the specific vaccine that v-safe information sheet telling them checked for any updates that may occur. an individual receives, but the most how to enroll in v-safe. Individuals who Additional adverse events following common may include pain at the enroll will receive regular text messages vaccination may be reported to VAERS. injection site, tiredness, headache, directing them to surveys where they Adverse events will also be monitored muscle pain, nausea, vomiting, fever, can report any problems or adverse through electronic health record- and and chills.25 After a review of all reactions after receiving a COVID–19 claims-based systems (that is, CDC’s available information, ACIP and CDC vaccine, as well as receive reminders for Vaccine Safety Datalink and Biologicals have determined the lifesaving benefits a second dose if applicable.27 We note Effectiveness and Safety (BEST)). On again that participation in v-safe is not December 11, 2020, the U.S. Food and 22 https://www.cdc.gov/coronavirus/2019-ncov/ mandatory, and further that individual Drug Administration issued the first prevent-getting-sick/prevention.html. 23 https://www.cdc.gov/mmwr/volumes/69/wr/ 26 See Centers for Disease Control and Prevention. 28 https://www.fda.gov/emergency-preparedness- mm6949e1.htm. Benefits of Getting a COVID–19 Vaccine. https:// and-response/mcm-legal-regulatory-and-policy- 24 https://www.kff.org/racial-equity-and-health- www.cdc.gov/coronavirus/2019-ncov/vaccines/ framework/emergency-use-authorization. policy/issue-brief/racial-diversity-within-covid-19- vaccine-benefits.html. Updated January 5, 2021. 29 Department of Health and Human Services. vaccine-clinical-trials-key-questions-and-answers/. Accessed January 14, 2021. VAERS—Vaccine Adverse Event Reporting System. 25 https://www.cdc.gov/coronavirus/2019-ncov/ 27 https://www.cdc.gov/coronavirus/2019-ncov/ Accessed at https://vaers.hhs.gov/. Accessed on vaccines/expect/after.html. vaccines/faq.html. January 26, 2021.

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EUA for a vaccine for the prevention of NHSN to support COVID–19 uptake or refusal of influenza and coronavirus disease 2019 (COVID–19) vaccination programs by focusing on pneumococcal immunization in the caused by severe acute respiratory groups or locations that would benefit resident’s medical record and report syndrome coronavirus 2 (SARS–CoV–2) from additional resources and strategies through a different electronic in individuals 16 years of age and older. that promote vaccine uptake. CMS submission system, the Minimum Data The EUA allows the Pfizer-BioNTech Federal surveyors and state agency Set (MDS). In order to standardize COVID–19 vaccine to be distributed in surveyors will use the vaccination data COVID–19 infection control and the U.S. FDA has now issued EUAs for in conjunction with the reported data prevention in LTC facilities, we are three vaccines for the prevention of that includes COVID–19 cases, resident issuing these requirements for facilities COVID–19, to Pfizer (December 11, deaths, staff shortages, PPE supplies and to provide COVID–19 vaccine 2020) (16 years of age and older), testing. This combination of reported education, offer COVID–19 vaccination, Moderna (December 18, 2020) (18 years data is used by surveyors to determine and report COVID–19 vaccinations for of age and older), and Johnson & individual facilities that need to have LTC facility residents and staff. Johnson’s Janssen (February 27, 2021) focused infection control surveys. We require ICFs–IID to provide or (18 years of age and older). Fact sheets Facilities having difficulty with vaccine obtain health care services for clients, for healthcare providers administering acceptance can be identified through including immunization, using as a vaccine are available for each vaccine examining trends in NHSN data; and the guide the recommendations of the CDC product from theFDA.30 Quality Improvement Organizations Advisory Committee on Immunization FDA is closely monitoring the safety (QIOs), groups of health quality experts, Practices or of the Committee on the of the COVID–19 vaccines authorized clinicians, and consumers organized to Control of Infectious Diseases of the for emergency use. The vaccination improve the quality of care delivered to American Academy of Pediatrics.32 provider is responsible for mandatory people with Medicare, can provide While the ICF–IID CoPs do not currently reporting to VAERS of certain adverse assistance to increase vaccine address specific vaccinations, the events as listed on the Health Care acceptance. Specifically, QIOs may unprecedented risk of COVID–19 illness Provider Fact Sheet. The requirements provide assistance to LTC facilities by demands specific attention to protect for LTC facilities and ICFs–IID targeting small, low performing, and clients. As discussed in section B.3. of established by this IFC can be met by rural nursing homes most in need of this IFC, we are not issuing COVID–19 offering current and future COVID–19 assistance, and those that have low vaccination reporting requirements for vaccines authorized by FDA under EUA, COVID–19 vaccination rates; ICFs–IID at this time due to current low or any COVID–19 vaccines licensed by disseminating accurate information rates of participation in NHSN by ICFs– FDA, as well as any COVID–19 vaccine related to access to COVID–19 vaccines IID and the delays that would be boosters if authorized or licensed. We to facilities; educating residents and incurred by equipment acquisition (in note that at this time, some LTC facility staff on the benefits of COVID–19 some facilities) and NHSN enrollment, residents and ICF–IID clients may not be vaccination; understanding nursing verification, and training. eligible to receive vaccination due to age home leadership perspectives and assist (that is, they are younger than 16), but them in developing a plan to increase A. Long-Term Care Facilities we anticipate that they may become COVID–19 vaccination rates among 1. Offer and Provide Vaccine to LTC eligible for vaccination if authorized use residents and staff; and assisting Residents and Staff of COVID–19 vaccines is expanded in providers with reporting vaccinations the future. accurately. With this IFC, we are amending the As discussed in detail below, we are requirements at § 483.80 to add a new II. Provisions of the Interim Final Rule revising the LTC facility requirements to paragraph (d)(3). We require at new In order to help protect LTC residents specify that facilities must educate all § 483.80(d)(3)(i) that LTC facilities and ICF–IID clients from COVID–19, residents and staff about COVID–19 develop and implement policies and each facility must have a vaccination vaccines, offer vaccination to all procedures to ensure that they offer program that meets the educational and residents and staff, and report certain residents and staff vaccination against information needs of each resident, data regarding vaccination and COVID–19 when vaccine supplies are resident representative, client, parent (if therapeutic treatments to CDC via available. We note that we are the client is a minor) or legal guardian, NHSN. Likewise, we are revising the permitting but not requiring LTC and staff member. The program should ICF–IID Conditions of Participation to facilities to provide the vaccine directly. provide COVID–19 vaccines, when require that facilities must educate all They may also provide it indirectly, available, to all residents and staff who clients and staff about COVID–19 such as through arrangement with a choose to receive them. Consistent vaccines and offer vaccination to all pharmacy partner or local health vaccination reporting by LTC facilities clients and staff. Reporting is not department. Implementation of COVID– via the NHSN will help to identify LTC required for the ICFs–IID, however we 19 vaccine education and vaccination facilities that have potential issues with strongly encourage voluntary reporting. programs in LTC facilities will protect vaccine confidence or slow uptake Immunization education, delivery, residents and staff, allowing for an among either residents or staff or both. and reporting for influenza and expedited return to more normal The NHSN is the Nation’s most widely pneumococcal vaccines are already a routines, including timely preventive used health care-associated infection routine part of LTC facilities’ infection health care; family, caregiver, and (HAI) tracking system. It furnishes control and prevention plans. We also community visitation; and group and states, facilities, regions, and the require LTC facilities to offer education individual activities. While we require Government with data regarding on influenza and pneumococcal that all residents and staff must be problem areas and measures of progress. vaccines and to give the resident or the educated about the vaccine, we note CDC and CMS use information from resident representative the opportunity that in situations, for example, where an to accept or refuse vaccine.31 LTC individual has already received a 30 https://www.fda.gov/media/144637/download, facilities must document a resident’s https://www.fda.gov/media/144413/download, 32 https://pediatrics.aappublications.org/content/ https://www.fda.gov/media/146304/download. 31 § 483.80(d). 145/3/e20193995.

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COVID–19 vaccine or has a known vaccination clinic, concluding in all facilities.37 For example, the website medical contraindication (that is, an facilities by spring of 2021. Internal CDC currently has ‘‘Long-Term Care Facility allergy to vaccine ingredients or data shows that 99 percent of Toolkit: Preparing for COVID–19 in LTC previous severe reaction to a vaccine), participating SNFs had held their third facilities’’ 38 and the ‘‘Interim Infection the facility is not required to offer (final) clinic as of March 15, 2021. As Prevention and Control vaccination to that person. CDC has the Pharmacy Partnership for LTC Recommendations for Healthcare posted ‘‘Interim Clinical Considerations program comes to an end, it is important Personnel During the Coronavirus for Use of COVID–19 Vaccines Currently to ensure facilities have policies and Disease 2019 (COVID–19) Pandemic.’’ 39 Authorized in the United States’’ procedures to provide continued access These recommendations, which describing these clinical situations.33 to COVID–19 vaccine for new or emphasize close monitoring of residents CDC advice and guidance documents unvaccinated residents and staff, groups of long-term care facilities for symptoms are periodically updated to reflect the that will each exceed in magnitude over of COVID–19, universal source control, latest information, and we cite this as an the course of this year a number larger physical distancing, hand hygiene, and example, not as a regulatory than those offered vaccination during optimizing engineering controls, are requirement. At § 483.70(i)(1), in the Partnership’s tenure. The Federal intended to help protect staff and accordance with accepted professional Government has also launched the residents from exposure. standards and practices, the LTC facility Federal Retail Pharmacy Program, a Administration of any vaccine must maintain medical records on each collaboration between the Federal includes appropriate monitoring of resident that are complete and Government, states, and territories, and vaccine recipients for adverse reactions. accurately documented. In order to 21 national pharmacy partners and CDC has information describing IPC maintain current information, refusal of independent pharmacy networks considerations for residents of long-term a vaccine should be documented with representing over 40,000 pharmacies care facilities with systemic signs and the reason; if the resident received the nationwide, including LTC facility symptoms following COVID–19 vaccine(s) elsewhere that should also be pharmacy locations. This collaboration vaccination. See ‘‘Post-Vaccine documented. is intended to enhance the opportunities Considerations for Residents,’’ located CDC established the Pharmacy for vaccine uptake in congregate living at https://www.cdc.gov/coronavirus/ Partnership for Long-term Care Program settings. 2019-ncov/hcp/post-vaccine- (Pharmacy Partnership), a national For residents and staff who opt to considerations-residents.html. This distribution initiative that provides end- receive the vaccine, vaccination must be information is also included on FDA to-end management of the COVID–19 conducted in a safe and sanitary manner fact sheets. Long-term care facilities vaccination process, including cold in accordance with § 483.80; and as must have strategies in place to chain management, on-site vaccinations, required by the vaccine provider appropriately evaluate and manage post- and fulfillment of certain reporting agreements, COVID–19 vaccination vaccination signs and symptoms of requirements, to facilitate safer clinics must be conducted in a manner adverse events among their residents. vaccination of the LTC facility for safe delivery of vaccines during the CDC advises that COVID–19 population (residents and staff), while COVID–19 pandemic.35 All facilities vaccination providers document vaccine reducing burden on LTC facilities and administration in their medical records 34 must adhere to current CDC infection jurisdictional health departments. prevention and control (IPC) system within 24 hours of Most LTC facility staff who had not recommendations. Screening administration and report received their COVID–19 vaccine individuals for currently suspected or administration data as specified in their elsewhere, or needed to complete a confirmed cases of COVID–19, previous vaccine provider agreements and to vaccine series, were also vaccinated as allergic reactions, and administration of applicable local vaccine tracking part of the program. At the time of therapeutic treatments and services is programs (that is, Immunization publication, we do not have data on the important for determining whether Information System) as soon as Partnership accomplishments in these individuals are appropriate practicable and no later than 72 hours vaccinating residents or staff, but as candidates for vaccination at any given after administration. While LTC facility discussed in the Regulatory Impact time. According to current CDC staff may not have personal medical Analysis (RIA) section of this rule, there guidelines, anyone infected with records on file with the employing LTC is extensive turnover in both groups, COVID–19 should wait until infection facility, all staff COVID–19 vaccinations establishing the need for ongoing must be appropriately documented by vaccination policies and programs. resolves and they have met the criteria for discontinuing isolation.36 We note the facility in a manner that enables the The Pharmacy Partnership is facility to report in accordance with this currently facilitating safe vaccination of that indications and contraindications for COVID–19 vaccination are evolving, rule (that is, in a facility immunization some LTC facility residents and staff, record, personnel files, health while reducing the burden on LTC and LTC facility Medical Directors and Infection Preventionists (IPs) should be information files, or other relevant facilities. The facilities remain document). Updates to CDC’s COVID–19 responsible for the care and services alert to any new or revised guidelines issued by CDC, FDA, vaccine Vaccination Program Provider provided to their residents. CDC has Agreement Requirements can be located expected pharmacy partners to provide manufacturers, or other expert on CDC’s website.40 program services on-site at participating stakeholders. facilities for approximately two months Staff at LTC facilities should follow the recommended IPC practices 37 https://www.cdc.gov/longtermcare/. from the date of each facility’s first 38 https://www.cdc.gov/vaccines/covid-19/ described on CDC’s website for LTC toolkits/long-term-care/. 33 https://www.cdc.gov/vaccines/covid-19/info- 39 https://www.cdc.gov/coronavirus/2019-ncov/ by-product/clinical-considerations.html 35 https://www.cdc.gov/vaccines/pandemic- hcp/infection-control-recommendations.html. 34 https://www.cdc.gov/vaccines/covid-19/long- guidance/index.html. 40 Centers for Disease Control and Prevention. term-care/pharmacy-partnerships.html and provide 36 Interim Guidance on Duration of Isolation and CDC COVID–19 Vaccination Program Provider additional information on vaccination under this Precautions for Adults with COVID–19 | CDC, Requirements and Support. Accessed at https:// program: https://covid.cdc.gov/covid-data-tracker/ https://www.cdc.gov/coronavirus/2019-ncov/hcp/ www.cdc.gov/vaccines/covid-19/vaccination- #vaccinations-ltc duration-isolation.html. Continued

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2. COVID–19 Disease and Vaccine contract or arrangement, including including contract staff, students, and Education hospice and dialysis staff, physical other non-employees.41 We are requiring that LTC facility staff a. LTC Facility Staff therapists, occupational therapists, mental health professionals, or (that is, individuals who work in the Given the new and emerging nature of volunteers. Any of these individuals facility on a regular basis) be educated COVID–19 disease, vaccines, and who provide services on-site at least about the benefits and risks and treatments, we recognize that education potential side effects of the COVID–19 is critical. With this IFC, we are weekly would be included in ‘‘staff’’ who must be educated and offered the vaccine. Educating staff further about amending the requirements at § 483.80 the development of the vaccine, how the vaccine as it becomes available. As to add new paragraph (d)(3)(ii) to vaccine works, and the particulars of the established by this rule at § 483.80(d)(3), require that LTC facility staff are multi-dose vaccine series is encouraged educated about vaccination against LTC facilities are not required to but not required. Broader understanding COVID–19. LTC facility staff are integral educate and offer vaccination to of the vaccine will support the national to the function of LTC facilities and the individuals who provide services less effort to vaccinate against COVID–19. health and well-being of residents. For frequently, but they may choose to Staff should be instructed about the the purposes of COVID–19 vaccine extend such efforts to them. We strongly importance of vaccination for residents, education, offering, and reporting, we encourage facilities, when the their personal health, and community consider LTC facility staff to be those opportunity exists and resources allow, health. Better understanding the value individuals who work in the facility on to provide vaccination to all individuals of vaccination may allow staff to a regular (that is, at least once a week) who provide services less frequently. appropriately educate residents and basis. We note that this includes those There are also individuals who may residents’ family members and unpaid individuals who may not be physically caregivers about the benefits of in the LTC facility for a period of time enter the facility for specific purposes and for a limited amount of time, such accepting the vaccine. While most due to illness, disability, or scheduled residents in LTC facilities are isolated as delivery and repair personnel, or time off, but who are expected to return from the broader community during the volunteers who may enter the LTC to work. We also note that this PHE, staff travel to and from the facility description of staff differs from that in facility infrequently (less than once a and the community, presenting risks of § 483.80(h), established for the LTC week). We believe it would be overly transmitting the virus to or from facility COVID–19 testing requirements burdensome to mandate that each LTC residents, family members, other in the September 2nd, 2020 COVID–19 facility educate and offer the COVID–19 caregivers, and the public. IFC. This rule’s description of LTC vaccine to all individuals who enter the We note that for LTC facilities that facility staff is limited to individuals facility. However, while facilities are participated in the Federal Pharmacy working in the facility on a regular (at not required to educate and offer Partnership for Long-Term Care least weekly) basis, while the definition vaccination to these individuals, they Program, pharmacies worked directly set out at § 483.80(h) includes workers may choose to extend their education with LTC facilities to ensure staff who who come into the facility infrequently, and offering efforts beyond those received the vaccine also received an such as a plumber who may come in persons that we consider to be staff for EUA fact sheet before vaccination. The only a few times per year. We purposes of this rulemaking. We do not EUA fact sheet explains the risks and considered applying the § 483.80(h) intend to prohibit such extensions and possible side effects and benefits of the definition to the vaccination and encourage facilities to educate and offer COVID–19 vaccine they are receiving reporting requirements in this rule, but vaccination to these individuals as and what to expect. Staff education must cover the public feedback tells us the definition in reasonably feasible. paragraph (h) was overbroad for these benefits of vaccination, which typically purposes. Stakeholders report that there We recognize that facilities may include reduced risk of COVID–19 are many LTC facility staff and choose to use a broader definition of illness and related serious COVID–19 individuals providing occasional ‘‘staff.’’ We note that CDC defines outcomes, including hospitalization and services under arrangement, and that ‘‘staff’’ in the NHSN as: Ancillary death, the bolstered protection offered the requirements may be excessively service employees, nurse employees, by completing a full series of multi-dose burdensome for the facilities to apply aide, assistant and technician vaccines if used, and other benefits the definition at paragraph (h) because employees, therapist employees, identified as research continues. Early it includes many individuals who have physician and licensed independent data also suggests that vaccination offers very limited, infrequent contact with practitioner employees and other health reduced risk of inadvertently facility staff and residents. Stakeholders care providers. Categories are further transmitting the virus to patients and 42 also report that providing the required broken down into environmental, other contacts. Staff education must education and offering vaccination to laundry, maintenance, and dietary also address risks associated with these individuals who may only make services; registered nurses and licensed vaccination, which should include potential side-effects of the vaccine, unscheduled visits to the facility would practical/vocational nurses; certified including common reactions such as be extremely burdensome. That said, the nursing assistants, nurse aides, aches or fever, and rare reactions such description in this rule—individuals medication aides, and medication who work in the facility on a regular as anaphylaxis.43 The low likelihood of assistants; therapists (such as severe side effects should be included in (that is, at least once a week) basis—still respiratory, occupational, physical, includes many of the individuals this education. If other benefits or risks speech, and music therapist) and or possible side-effects are identified in included in paragraph (h). In addition to therapy assistants; physicians, residents, facility-employed personnel, many fellows, advanced practice nurses, and 41 facilities have services provided on-site, https://www.cdc.gov/nhsn/ltc/weekly-covid- physician assistants; and persons not vac/index.html. on a regular basis by individuals under included in the employee categories 42 https://www.cdc.gov/coronavirus/2019-ncov/ listed, regardless of clinical vaccines/fully-vaccinated.html. provider-support.html. Accessed on January 26, 43 https://www.cdc.gov/coronavirus/2019-ncov/ 2021. responsibility or patient contact, vaccines/expect/after.html.

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the future, whether through research, or sessions. There may be posters and specifically prohibit charging out-of- authorization or licensing of new flyers announcing appointments for pocket fees to the vaccine recipient. COVID–19 vaccines, those facts should vaccine clinic days or other Medicare pays for the administration of be incorporated into education efforts. opportunities to be vaccinated. the COVID–19 vaccine to beneficiaries, and other public and private insurance Staff should also be informed about b. LTC Facility Residents and Resident ongoing opportunities for vaccination, if Representatives providers are required to cover it as they miss a Pharmacy Partnership well. To ensure broad access to a clinic, for example, or initially declined With this IFC, we are amending the vaccine for America’s Medicare vaccination but later decide to accept requirements at § 483.80 to add a new beneficiaries, CMS published an Interim the vaccine. In addition to ongoing paragraph (d)(3)(iii) to require that LTC Final Rule with Comment Period (IFC) education and informational updates for facility residents or resident on November 6, 2020, that implemented all staff members, we expect that new representatives are educated about section 3713 of the Coronavirus Aid, staff will receive appropriate education vaccination against COVID–19. Relief, and Economic Security (CARES) on COVID–19 vaccines. Explaining the risks and possible side Act which required Medicare Part B to CDC and FDA have developed a effects and benefits of any treatments to cover and pay for a COVID–19 vaccine variety of clinical educational and a resident or their representative in a and its administration without any cost- training resources for health care way that they can understand is the sharing (85 FR 71142, November 6, professionals related to COVID–19 standard of care, and a patient right as 2020). Any vaccine that receives Food vaccines, and CMS recommends that specified at § 483.10(c)(5). In LTC and Drug Administration (FDA) nurses and other clinicians work with facilities, consent or assent for authorization, through an EUA, or is their LTC facility’s Medical Director vaccination should be obtained from licensed under a Biologics License and, and use CDC and FDA resources as residents and/or their representatives as Application (BLA), will be covered sources of information for their appropriate and documented in the under Medicare as a preventive vaccine vaccination education initiatives. The resident’s medical record. The residents at no cost to beneficiaries. The LTC Facility Toolkit: Preparing for or their representatives have the right to November 6th IFC also implemented COVID–19 Vaccination at Your Facility decline the vaccine, based on the section 3203 of the CARES Act that has information and resources to build resident’s rights requirement at ensure swift coverage of a COVID–19 confidence among staff and residents.44 § 483.10(c)(5) (regarding the resident’s vaccine by most private health right to be informed of risks and benefits The FDA provides materials for industry insurance plans without cost sharing of proposed care). It is important to talk and other stakeholder specific to the from both in and out-of-network to residents and representatives to learn EUA process and the vaccines.45 providers during the course of the why they may be declining vaccination Examples of educational and training PHE.46 The Provider Relief Fund on their own behalf, or on behalf of the topics include engaging residents in Uninsured Program will also reimburse resident, and tailor any educational effective COVID–19 vaccine for administration of COVID–19 vaccine messages accordingly. Residents may conversations, answering questions to individuals who are uninsured.47 not be forced or required to be about consent for vaccine, common side vaccinated if the person or their Education for residents and effects, educating residents and staff representative declines. representatives must also provide the about what to expect after vaccination, Resident representatives must be opportunity for follow-up questions and and the importance of maintaining included as a component of the LTC be conducted in a manner that is infection prevention and control facility’s vaccine education plan, as the reasonably understood by the resident practices after vaccination. Each vaccine resident representatives may be called and the representatives. manufacturer is also developing upon for consent and/or may be asked 3. LTC Facility Reporting educational and training resources for to assist in promoting vaccine uptake of its individual vaccine. Building vaccine the resident, as appropriate. We note With this IFC, we are amending the understanding broadly among staff, that for LTC facilities participating in requirements at § 483.80(g) to require residents, and resident representatives, the Federal Pharmacy Partnership for that LTC facilities report to NHSN, on as well as dispelling vaccine Long-term Care Program, pharmacies a weekly basis, the COVID–19 misinformation and spreading will work directly with LTC facilities to vaccination status and related data information about successes in the ensure residents who receive the elements of all residents and staff. The program are critical to improving vaccine also receive an EUA fact sheet data to be reported each week will be vaccine uptake rates, with potential for before vaccination. The EUA fact sheet cumulative, that is, data on all residents reducing vaccine hesitancy and the explains the risks or potential side and staff, including total numbers and spread of misinformation. effects and benefits of the COVID–19 those who have received the vaccine, as The facility’s vaccination policies and vaccine they are receiving and what to well as additional data elements. In this procedures must be part of the IPC expect. way, the vaccination status of every LTC program. Facilities can determine where In addition to the topics addressed facility will be known on a weekly they keep the documentation that above for education of LTC facility staff, basis. Data on vaccine uptake will be demonstrates educational efforts and education of residents and resident important to understanding the impact offering the vaccine to staff. Some representatives should cover that, at this of vaccination on SARS–CoV–2 examples of evidence of compliance time while the U.S. Government is infections and transmission in nursing may include sign in sheets, descriptions purchasing all COVID–19 vaccine in the of materials used to educate, summary United States for administration through 46 Medicare and Medicaid Programs, Clinical notes from all-staff question and answer the CDC COVID–19 Vaccination Laboratory Improvement Amendments (CLIA), and Program, all LTC facility residents are Patient Protection and Affordable Care Act; 44 https://www.cdc.gov/vaccines/covid-19/ able to receive the vaccine without any Additional Policy and Regulatory Revisions in toolkits/long-term-care/. Response to the COVID–19 Public Health 45 https://www.fda.gov/emergency-preparedness- copays or out-of-pocket costs. The Emergency (85 FR 54820). and-response/counterterrorism-and-emerging- provider agreements for the CDC 47 https://www.hhs.gov/coronavirus/cares-act- threats/coronavirus-disease-2019-covid-19. COVID–19 Vaccination Program provider-relief-fund/index.html.

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homes.48 This understanding, in turn, publicly report this information to NHSN and familiarity with the NHSN will help CDC make changes to support protecting the health and safety process will also increase the future guidance to better protect residents and of residents, staff, and the general capacity of facilities to report if new staff in LTC facilities. In addition, LTC public, in accordance with sections pandemics or other threats arise in the facilities must also report any COVID– 1819(d)(3)(B) and 1919(d)(3) of the Act. future. Aggregate COVID–19 vaccination data 19 therapeutics administered to Pharmacy partners reported residents. CDC has currently defined collected as a result of this rulemaking will be made available to the public in vaccination clinics they held in LTC ‘‘therapeutics’’ for the purposes of the facilities, and they have shared these NHSN as a ‘‘treatment, therapy, or drug’’ the future. We note that until that time, data with CDC. Internal CDC data shows and stated that monoclonal antibodies individuals may request data per the that 99 percent of participating SNFs are examples of anti-SARS–CoV–2 Freedom of Information Act (FOIA) (5 had held their 3rd (final) clinic as of antibody-based therapeutics used to U.S.C. 552), which provides that, upon March 15, 2021. However, they have not help the immune system recognize and request from any person, a Federal continued to collect or report these data respond more effectively to the SARS- agency must release any agency record CoV–2 virus. unless that record falls within one of the after their clinics concluded. LTC administrators and clinical nine statutory exemptions and three Additionally, the pharmacy partners leadership are encouraged to track exclusions (see https://www.foia.gov/ only collected numerator data (the vaccination coverage in their facilities faq.html for detailed information). number of residents and staff and adjust communication with Further, FOIA requires that agencies vaccinated), and not denominator data residents and staff accordingly. make available for public inspection (the total number of residents and staff). Facilities reporting vaccinations to the copies of records, which because of the Therefore, CDC cannot calculate the NHSN Long-Term Care Facility nature of their subject matter, have percentages of residents and staff Component 49 or Healthcare Personnel become or are likely to become the vaccinated in each facility via the Safety Component are encouraged to use subject of subsequent requests for Federal Pharmacy Partnership data. the COVID–19 Vaccination module to substantially the same information. We NHSN provides the long-term means track aggregate vaccination coverage in have received, and expect to continue to to collect these data now that the their facility, which can help target receive, COVID–19-related FOIA Pharmacy Partnership has finished and requests. Facility influenza vaccine data education efforts, plan resource needs, will allow for calculation of percentages are available through CMS’s Care and update visitation and cohorting of residents and staff vaccinated in Compare tool because these data are policies (that is, grouping residents every facility. We anticipate that the within the facility while waiting for collected directly through the MDS, which feeds into the Care Compare tool. additional reporting burden to LTC COVID–19 test results or showing signs facilities will be minimal. All LTC of illness) as indicated by evolving Data submitted through NHSN concerning COVID–19 testing and cases facilities are already required, at public health guidelines. NHSN data § 483.80(g), to report certain COVID–19 will allow CDC to determine the number in LTC facilities is publicly posted on 51 case and outcomes data to NHSN every and percentage of staff and residents in data.cms.gov. We are aware that COVID–19 vaccine week, and the new vaccination each facility who have received the reporting is in the same NHSN reporting 50 information may be reported to local COVID–19 vaccine. system they currently use. Finally, Our intent in mandating reporting of and state health departments, as well as health departments for states, the COVID–19 vaccines and therapeutics to by various pharmacy partners, and we District of Columbia, and territories all NHSN is in part to monitor broader believe direct submission of data by have access to NHSN data for their community vaccine uptake, but also to LTC facilities through NHSN will show jurisdictions and can use these data to allow CDC to identify and alert CMS to actions and trends that can be addressed facilities that may need additional more efficiently on a national level. All inform their own response efforts. support in regards to vaccine education state health departments and many local Facilities can determine where they and administration. These specific data health departments already have direct keep the documentation that should be collections replace and refine the access through NHSN to LTC facilities’ collected so that they can comply with COVID–19 data and are using the data current requirement, set out at the NHSN COVID–19 vaccination for their own local response efforts. § 483.80(g)(1)(viii), based on the reporting requirements for staff. Thus, reporting in NHSN will, in many opportunities presented by the Therapeutic treatments for COVID–19 cases, serve the needs of state and local development and authorization of administered to LTC residents, such as health departments. We request public COVID–19 vaccines and therapeutic those in the form of monoclonal comment on whether states are treatments. If we identify a need to collecting COVID–19 vaccination data antibodies delivered intravenously, collect other specific data related to already, through other mechanisms. must now also be reported through COVID–19, we will do this through National reporting through NHSN, NHSN in accordance with new appropriate rulemaking. The which is limited to enrolled health care § 483.80(g)(1)(ix) so that CDC can information reported to CDC in providers, will allow CDC to examine appropriately monitor their use. This accordance with § 483.80(g) will be vaccination coverage compared with reporting of therapeutics requirement is shared with CMS and we will retain and community infection rates, to determine similar to the requirement that hospitals visitation and other COVID–19 infection must report information about 48 https://www.cdc.gov/nhsn/pdfs/covid19/ltcf/ prevention and control guidelines, therapeutics (85 FR 85866). Data on the 57.158-toi-508.pdf. use of therapeutics will be critical to 49 Centers for Disease Control and Prevention— including cohorting. Currently, low National Healthcare Safety Network. Surveillance rates of voluntary use of NHSN for help support allocation efforts to ensure for Weekly HCP & Resident COVID–19 Vaccination. vaccination reporting precludes that nursing homes have access to Accessed at https://www.cdc.gov/nhsn/ltc/weekly- accurate estimates of vaccine coverage. supplies and services to meet their covid-vac/index.html. Accessed on January 26, 2021. Regular and required reporting into the needs. This requirement and burden 50 https://www.cdc.gov/nhsn/ltc/weekly-covid- will be submitted to OMB under OMB vac/index.html. 51 https://www.medicare.gov/care-compare/. control number 0938–1363.

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B. Intermediate Care Facilities for cases of COVID–19, previous allergic reactions among any individuals who Individuals With Intellectual Disabilities reactions, and administration of are vaccinated on site, and risks and therapeutic treatments is important for potential side effects of vaccination on 1. Offer and Provision of Vaccine to determining whether they are clients. ICF–IID Clients and Staff appropriate candidates for vaccination CDC advises that COVID–19 With this IFC, we are redesignating at any given time. According to current vaccination providers should document the current § 483.460(a)(4) to CDC guidelines, anyone infected with vaccine administration in their medical § 483.460(a)(5) and adding a COVID–19 should wait until infection records within 24 hours of requirement at new § 483.460(a)(4)(i) to resolves and they have met the criteria administration and report require that ICFs–IID offer clients and for discontinuing isolation.54 We note administration data as specified in their staff vaccination against COVID–19 that indications and contraindications vaccine provider agreements and to when vaccine supplies are available. for COVID–19 vaccination are evolving, applicable local vaccine tracking The vaccine may be offered and and the director of nursing (DON) or programs (that is, Immunization provided directly by the ICF–IID or nursing staff of the facility should be Information System). While an ICF–IID indirectly, such as through a local alert to any new or revised guidelines is unlikely to be a COVID–19 health department, pharmacy, or issued by CDC, FDA, vaccine vaccination provider, all vaccinations doctor’s office. Vaccines may be manufacturers, and other expert should be appropriately documented. administered onsite or at other stakeholders. While ICF–IID staff may not have appropriate locations. Implementation Staff at ICFs–IID should follow the personal medical records with the ICF– of COVID–19 education and vaccination recommended IPC practices described IID, ICFs–IID participating in voluntary programs in ICFs–IID will help protect on CDC’s website for ICFs–IID. For NHSN reporting should appropriately clients and staff, allowing an eventual example, the website currently has document staff vaccinations in a manner return to more normal routines, documents entitled ‘‘Guidance for that enables the facility to report in including timely preventive health care; Group Homes for Individuals with accordance with NHSN guidelines (that family, caregiver and community Disabilities’’ and the ‘‘Interim Infection is, in a facility immunization record, visitors; and group and individual Prevention and Control personnel files, health information files, activities. While we require that all Recommendations for Healthcare or other relevant documentation). clients and staff must be educated about Personnel During the Coronavirus 2. COVID–19 Disease and Vaccine the vaccine, we note that in situations Disease 2019 (COVID–19) where an individual has already Education Pandemic’’.55 56 These received the vaccine or has a known recommendations, which emphasize a. ICF–IID Staff medical contraindication (that is, an close monitoring of clients of group allergy to vaccine ingredients or Given the new and emerging qualities homes for individuals with disabilities previous severe reaction to a vaccine), of COVID–19 disease, vaccines, and or ICFs–IID for symptoms of COVID–19, the facility is not required to offer treatments we recognize that education universal source control, physical vaccination to that person.52 of clients and staff is critical. With this The client, parent (if the client is a distancing, use of masks, hand hygiene, IFC, we are amending the conditions of minor), or legal guardian (collectively, and optimizing engineering controls, are participation at new § 483.460(a)(4)(ii) ‘‘representative’’) has the right to refuse intended to protect staff, residents, and to require that ICF–IID staff are educated treatment based on the requirement at visitors from exposure to SARS-CoV–2. about vaccination against COVID–19. § 483.420(a)(2) that states the facility Administration of any vaccine ICF–IID staff are integral to the function must ensure the rights of all clients. includes appropriate monitoring of of the ICFs–IID and the health and well- Therefore, the facility must inform each vaccine recipients for adverse reactions. being of clients. For the purposes of client and/or the representative For the COVID–19 vaccines, safety COVID–19 vaccine education and 57 regarding the client’s medical condition, monitoring is also being conducted. offering, we consider ICF–IID staff to be developmental and behavioral status, CDC has information describing IPC those individuals who work in the attendant risks of treatment, and the considerations for residents of ICF–IIDs facility on a regular (that is, at least once right to refuse treatment. Clients and with systemic signs and symptoms a week) basis. We note that this includes their representatives (on behalf of the following COVID–19 vaccination. See those individuals who may not be client) have the right to refuse ‘‘Vaccine considerations for people with physically in the ICF–IID for a period of vaccination. disabilities,’’ located at https:// time due to illness, disability, or For clients and staff who opt to www.cdc.gov/coronavirus/2019-ncov/ scheduled time off, but who are receive the vaccine, vaccination must be vaccines/recommendations/ expected to return to work. In addition conducted in a sanitary manner in disabilities.html. Post-vaccine to facility-employed personnel, many accordance with CDC, FDA, § 483.410(b) considerations are listed out for facilities have services provided on-site, of the ICF–IID CoPs, and manufacturer consideration by ICFs–IID clinical staff. on a regular basis by individuals under guidelines. As required by the provider ICFs–IID must have strategies in place to contract or arrangement, including agreements, COVID–19 vaccination appropriately evaluate and manage hospice and dialysis staff, physical clinics must be conducted in a manner immediate post-vaccination adverse therapists, occupational therapists, for safe delivery of vaccines during the behaviorists, mental health COVID–19 pandemic.53 All facilities 54 Interim Guidance on Duration of Isolation and | professionals, and volunteers. These should adhere to current CDC IPC Precautions for Adults with COVID–19 CDC, https://www.cdc.gov/coronavirus/2019-ncov/hcp/ individuals would be included in recommendations. Screening duration-isolation.html. ‘‘staff’’ who must be educated and individuals for suspected or confirmed 55 https://www.cdc.gov/coronavirus/2019-ncov/ offered the vaccine as available. community/group-homes.html. There are also individuals who may 52 https://www.cdc.gov/coronavirus/2019-ncov/ 56 https://www.cdc.gov/coronavirus/2019-ncov/ enter the facility for specific purposes vaccines/recommendations/specific-groups/ hcp/infection-control-recommendations.html. allergies.html. 57 https://www.fda.gov/vaccines-blood-biologics/ and for a limited amount of time, such 53 https://www.cdc.gov/vaccines/pandemic- safety-availability-biologics/covid-19-vaccine- as delivery and repair personnel, or guidance/index.html. safety-surveillance. volunteers who may enter the ICF–IID

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infrequently (meaning less than once ICF–IID to educate and offer the educational and training resources for weekly). We believe it would be overly COVID–19 vaccine to all individuals health care professionals related to burdensome to mandate that each ICF– who enter the facility. Staff and COVID–19 vaccines, and CMS IID educate and offer the COVID–19 resources are limited in ICFs–IID, and recommends that nurses and other vaccine to all individuals who enter the therefore staff may not be available to clinicians work with their ICF–IID’s facility. However, while facilities are educate and offer the vaccine to every Medical Director and use CDC resources not required to educate and offer individual that enters. as the source of information for their vaccination to these individuals, they We are requiring that ICF–IID staff vaccination education initiatives. Each may choose to extend their education (that is, individuals who are eligible to manufacturer is also developing and offering efforts beyond those work in the facility on a routine, or at educational and training resources for persons that we consider to be ‘‘staff’’ least once weekly, basis) be educated its individual vaccine candidate. for purposes of this rulemaking. We do about the benefits and risks and Building vaccine understanding broadly not intend to prohibit such extensions potential side effects of the COVID–19 among staff, clients, and parent (if the and encourage facilities to educate and vaccine. Educating staff further about client is a minor), or legal guardian or offer vaccination to these individuals as the development of the vaccine, how the representative, as well as dispelling reasonably feasible. vaccine works, and the particulars of vaccine misinformation, are critical to We recognize that facilities may multi-dose vaccine series is encouraged vaccine uptake rates. choose to use a broader definition of but not required. Broader understanding The facility vaccination policies and ‘‘staff.’’ We note that CDC categorizes of the vaccine will support the national procedures must be developed as part of staff in the NHSN as: Ancillary service effort to vaccinate against COVID–19. the COVID–19 immunization employees, nurse employees, aides, Staff should be educated to help them requirements at § 483.460(a)(4). assistant and technician employees, understand the importance of Facilities can determine where they therapist employees, physician and vaccination for helping to safeguard keep the documentation that licensed independent practitioner clients, personal health, and broader demonstrates educational efforts and employees and other health care community health. Better understanding offering the vaccine to staff. Some providers. Categories are further broken of the value and safety of the vaccines examples of evidence of compliance down into environmental, laundry, will allow staff to appropriately educate may include sign in sheets, descriptions maintenance, and dietary services; clients and representatives about the of materials used to educate, and registered nurses (RNs) and licensed benefits of accepting the vaccine. summary notes from all-staff question practical/vocational nurses; certified Staff education must cover the and answer sessions. There may be nursing assistants, nurse aides, benefits and risks or possible side posters and flyers announcing medication aides, and medication effects of vaccination, which typically appointments for vaccine clinic days or assistants; therapists (such as include reduced risk of COVID–19 other vaccination opportunities. respiratory, occupational, physical, illness, and related serious COVID b. ICF–IID Clients speech, and music therapists) and outcomes, including hospitalization and therapy assistants; physicians, residents, death, the bolstered protection offered New § 483.460(a)(4)(iii) requires that fellows, advanced practice nurses, and by completing a full series of multi-dose ICF–IID clients, or their representatives physician assistants; and persons not vaccines (if used), and other benefits are educated about vaccination against included in the employee categories identified as research and immunization COVID–19. Explaining the risks and listed, regardless of clinical continues. Staff education must also benefits of any treatments to a client or responsibility or patient contact, address risks associated with representative in a way that they including contract staff, students, and vaccination, which should include understand is the standard of care. In other non-employees.58 potential side-effects of the vaccine, ICFs–IID, consent or assent for For purposes of the CMS including common reactions such as vaccination should be obtained from requirements related to COVID–19 aches or fever, and rare reactions such clients or representatives and education and vaccination issued in this as anaphylaxis. The low likelihood of documented in the client’s medical rule, we believe that the NHSN severe side effects should be included in record. It is important to talk to clients definition may be impractical. In this education. If other benefits, risks, or and representatives to learn why they addition to regularly employed side-effects are identified in the future, may be declining vaccination and tailor personnel, many facilities have services whether through research, or educational messages accordingly, that provided directly to residents under authorization or licensing of new is, by addressing specific questions or contract, such as physical therapy, COVID–19 vaccine products, those facts concerns. occupational therapy, behavior therapy, should be incorporated into education Clients of ICFs–IID and their case management, and mental health efforts. Staff should also be informed representatives must be offered services. There are also individuals who about ongoing opportunities for education about vaccine immunization may enter the facility for specific vaccination. Staff should be provided development, administration, and purposes and for a limited amount of education on culturally appropriate evaluation. Representatives must be time, such as delivery personnel, ways to educate and share information included as a component of the ICF– plumbers, and other vendors. Even with clients to prevent misinformation, IID’s vaccine education plan as the regular volunteers may enter the ICF– confusion, or loss of credibility. In representatives may be called upon for IID infrequently. We do not believe that addition to ongoing education and consent and/or may be asked to assist in mandating these requirements for every informational updates for all staff encouraging vaccine uptake by the individual who enters the facility at any members, we expect that new staff will client. time is necessary to protect the clients be screened to determine vaccination In addition to the topics addressed and staff. In addition, we believe it status, and potential need for above for education of ICF–IID staff, would be overly burdensome for the appropriate education on COVID–19 education of clients and representatives vaccines during their onboarding or should cover the fact that, at this time 58 https://www.cdc.gov/nhsn/ltc/weekly-covid- orientation. CDC and FDA have while the U.S. Government is vac/index.html. developed a variety of clinical purchasing all COVID–19 vaccine in the

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United States for administration through report vaccination data.59 Education these individuals as quickly as the CDC COVID–19 Vaccination and vaccine administration must be practicable. Further, we expect Program, all ICF–IID clients are able to reflected in facility policies and personnel records for facility staff and receive the vaccine without any copays procedures, as well as in staff and health records for residents and clients or out-of-pocket costs. Currently resident records. In addition, NHSN to reflect appropriate administration of Medicaid pays for the administration of reporting of vaccine and therapeutics any multi-dose vaccine series, including the COVID–19 vaccine to beneficiaries, must be reflected in facility policies and efforts to acquire subsequent doses as and other public and private insurance procedures, with evidence of data necessary. submission. For ICFs–IID, education providers are required to cover it as III. Waiver of Proposed Rulemaking well. and administration of the vaccine must be reflected in facility policies and We ordinarily publish a notice of Education for clients and procedures, as well as in staff and client proposed rulemaking in the Federal representatives must also provide the records. Updated guidance and Register and invite public comment on opportunity for follow up questions, information on reporting and the proposed rule before the provisions and be conducted in a manner that is enforcement of these new requirements of the rule are finalized, either as reasonably understood by the clients will be issued when this IFC is proposed or as amended in response to and representatives. Information should published. public comments, and take effect, in be made available in accessible formats We specify at §§ 483.80(d)(3)(i) and accordance with the Administrative as appropriate for a facility’s 483.460(a)(4)(i) that COVID–19 vaccines Procedure Act (APA) (Pub. L. 79–404), population. That is, educational must be offered when available. If a 5 U.S.C. 553, and, where applicable, materials and delivery must meet facility does not have access to the section 1871 of the Act. Specifically, 5 relevant standards in Section 504 of the vaccine, we expect the facility to U.S.C. 553 requires the agency to Rehabilitation Act, which may include provide, upon request, evidence that publish a notice of the proposed rule in making such material available in large efforts have been made to make the the Federal Register that includes a print, Braille, and American Sign vaccine available to its residents or reference to the legal authority under Language, and using close captioning, clients, and staff. For example, which the rule is proposed, and the audio descriptions, and plain language documentation of communications with terms and substance of the proposed for people with vision, hearing, the facility medical director, the local rule or a description of the subjects and cognitive, and learning disabilities. health department, or listing of issues involved. Further, 5 U.S.C. 553 3. ICF–IID Voluntary Reporting vaccination sites may be used to show requires the agency to give interested efforts to make the vaccine available to parties the opportunity to participate in While there would be great value in residents, clients, and staff. Similar to the rulemaking through public comment collecting more data about COVID–19 influenza vaccines, if there is a before the provisions of the rule take incidence and vaccinations in ICFs–IID, manufacturing delay, we ask the facility effect. Similarly, section 1871(b)(1) of we are not mandating such data to provide sufficient evidence of such. the Act requires the Secretary to provide submission at this time. Currently there The infection prevention and control for notice of the proposed rule in the are only approximately 80 ICFs–IID plan is designed to allow for Federal Register and a period of not less participating in the NHSN or any other documentation of vaccine efforts. While than 60 days for public comment for formal reporting program, although Pharmacy Partnership clinics are rulemaking carrying out the there are opportunities for ICFs–IID to currently the most common avenue for administration of the insurance enroll. Requiring all ICFs–IID to report delivering COVID–19 vaccines to LTC programs under title XVIII of the Act. to NHSN would create a new field of facilities, we expect all facilities to be Section 1871(b)(2)(C) of the Act and 5 administrative burden for ICFs–IID, prepared to participate in other U.S.C. 553 authorize the agency to potentially requiring new equipment, distribution programs (possibly through waive these procedures, however, if the administrative staff, and training. local health departments or traditional agency for good cause finds that notice Further, reporting through NHSN would pharmacies) as the vaccine continues to and comment procedures are require time, likely several weeks to become more widely available at a impracticable, unnecessary, or contrary months, for the facilities not yet multiplicity of sites. to the public interest and incorporates a participating in NHSN to complete If an individual resident, client, or statement of the finding and its reasons enrollment with CDC and appropriately staff member requests vaccination in the rule issued. Section 553(d) of title train those staff who would be against COVID–19, but missed earlier 5 of the U.S. Code ordinarily requires a responsible for data submission, opportunities for any reason (including 30-day delay in the effective date of a effectively making compliance within recent residency or employment, final rule from the date of its the effective date of this IFC nearly changing health status, overcoming publication in the Federal Register. impossible. Based on the information vaccine hesitancy, or any other reason), This 30-day delay in effective date can we have received from stakeholders, we we expect facility records to show be waived, however, if an agency finds do not believe that ICFs–IID are efforts made to acquire a vaccination good cause to support an earlier administering therapeutics at this time. opportunity for that individual. effective date. Section 1871(e)(1)(B)(i) of We encourage voluntary reporting as Although we are not establishing formal the Act also prohibits a substantive rule from taking effect before the end of the facilities are able to do so. timeframes within which vaccination must be arranged for new residents, 30-day period beginning on the date the C. Enforcement clients, or staff, we expect LTC facilities rule is issued or published. However, and ICFs–IID to support vaccination for section 1871(e)(1)(B)(ii) of the Act Enforcement of the provisions of this permits a substantive rule to take effect IFC for LTC facilities will be similar to 59 Social Security Act. Section 1819(h)(2)(B)(ii). before 30 days if the Secretary finds that those requirements addressing influenza Accessed at https://www.ssa.gov/OP_Home/ssact/ a waiver of the 30-day period is and pneumococcal vaccinations. We title18/1819.htm; and Social Security Act. Section 1919(h)(2)(A)(ii). Accessed at https://www.ssa.gov/ necessary to comply with statutory will impose civil money penalties if we OP_Home/ssact/title19/1919.htm. Both accessed on requirements or that the 30-day delay determine that the facility has failed to April 28, 2021. would be contrary to the public interest.

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Furthermore, section 1871(e)(1)(A)(ii) of chain challenges that exist with two of require LTC facilities to report the Act permits a substantive change in the three currently available vaccines vaccination status within their facility, regulations, manual instructions, that make obtaining and providing the we have no comprehensive way of interpretive rules, statements of policy, vaccine more challenging for small knowing whether residents or staff of or guidelines of general applicability facilities that do not have the necessary those facilities have acquired the under Title XVIII of the Act to be storage equipment. Ensuring the health vaccine through avenues outside the applied retroactively to items and and safety of all Americans, including Partnerships. Ensuring that individuals services furnished before the effective Medicare and Medicaid beneficiaries, residing in LTC facilities that did not date of the change if the failure to apply and health care workers is of primary participate in the Pharmacy the change retroactively would be importance. This IFC directly supports Partnerships have access to vaccination contrary to the public interest. Finally, that goal by requiring education about against COVID–19 is critical so as to the Congressional Review Act (CRA) and offer of COVID–19 vaccination for expeditiously ensure that residents are (Pub. L. 104–121, Title II) requires a 60- LTC facility and ICF–IID residents, protected. day delay in the effective date for major clients, and staff. This IFC also requires Most LTC facilities participated in the rules unless an agency finds good cause reporting of COVID–19 vaccination Pharmacy Partnerships but the that notice and public procedure are status and use of COVID–19 Partnerships concluded in March 2021. impracticable, unnecessary, or contrary therapeutics of LTC facility residents The Pharmacy Partnership program was to the public interest, in which case the and staff, which will provide vital data designed as time-limited effort designed rule shall take effect at such time as the that CMS, CDC, and other public health to quickly vaccinate thousands of agency determines. 5 U.S.C. 801(a)(3), entities can use to target our outreach facility residents per week. 808(2). and resources in support of vaccination. Ending the program without appropriate requirements to ensure A. COVID–19 and Populations at Higher B. Supporting Vaccine Distribution and facilities continue to seek vaccination Risk Uptake opportunities for their residents and On January 30, 2020, the International In response to the COVID–19 staff puts future incoming LTC facility Health Regulations Emergency pandemic, pharmaceutical developers residents and staff at risk. Turnover of Committee of the World Health around the world began development of both LTC facility residents (admissions Organization (WHO) declared the vaccine that would prevent severe and discharges) and staff can be outbreak a ‘‘Public Health Emergency of illness and death and they have significant. It is difficult to estimate the international concern.’’ On January 31, produced several vaccines authorized number of admissions and discharges in 2020, pursuant to section 319 of the for use in the United States. Because the LTC facilities as 20 to 25 percent of beds PHSA, the Secretary determined that a first cohort of authorized vaccines are often reserved for shorter term PHE exists for the United States to aid require specialized handling, and LTC (weeks to months) rehabilitation stays, the nation’s health care community in facility residents have been at higher while other individuals reside in the responding to COVID–19. On March 11, risk of severe illness from COVID–19, facility for years. That said, resident 2020, the WHO publicly declared CDC established the Pharmacy turnover within a year may be COVID–19 a pandemic. On March 13, Partnership for Long-Term Care (LTC) significant, possibly up to 40 percent 2020, the President declared the Program, which has facilitated on-site based on internal CMS estimates. Staff COVID–19 pandemic a national vaccination of residents and staff at turnover is more easily considered, with emergency. more than 63,000 enrolled nursing some estimates as high as 100 percent Over 569,000 individuals have lost homes and assisted living facilities for certain facilities within a year,62 and their lives to COVID–19 in the United while reducing the burden on facility if a facility finds itself with a large States as of April 27, 2021,60 including administrators, clinical leadership, and portion of its community being more than 131,000 LTC facility health departments. At no cost to unvaccinated, all residents and staff residents, or close to one tenth of the facilities, the program has provided end- may again face a higher risk of infection, average national LTC facility resident to-end management of the COVID–19 similar to the risk levels during the early census of 1.4 million.61 In recognition of vaccination process, including cold months of the pandemic. For example, the susceptibility of their residents, chain management, on-site vaccinations, if final Partnership vaccination rates clients, and staff, LTC facilities and and fulfillment of reporting reach even 90 percent (an illustrative other congregate settings, including requirements. example as we do not have final or ICFs–IID, have been prioritized for While the Pharmacy Partnerships complete data) of the residents present vaccination. The data show that have had much success in ensuring in the first 3 months of 2021, turnover COVID–19 cases are declining in LTC timely vaccine access to many LTC during the rest of the year may be such facilities concurrently with increasing facility residents and staff, we note that that by year-end as few as two-thirds of vaccination among residents and staff, not all such individuals were able to LTC residents present at some point but as noted below, we are concerned receive vaccine under the program. during the year would have been that the rate of vaccination in LTC Internal CDC data show that vaccinated absent a continuing and facilities may slow in the absence of approximately 2,500 or about 16 percent effective effort. regulation and the conclusion of the of CMS-certified SNFs (a subset of LTC Turnover rates demonstrate there will Pharmacy Partnership program, facilities enrolled as Medicare be an ongoing need for new resident or especially in light of consistent, providers) that are enrolled in NHSN staff vaccinations. For example, when frequent resident and staff turnover in did not participate in the Pharmacy the Pharmacy Partnership completes its these facilities and the cold storage Partnership program. LTC facility time commitment, it is likely that it will residents are unable to live have seen only about half of the persons 60 https://covid.cdc.gov/covid-data-tracker/ independently, and generally are unable who will reside or work in these #datatracker-home. to access the vaccine without significant 61 LTC Facility deaths are from COVID–19 facilities in 2021. Even if two-thirds of Nursing Home Data, CMS, Week Ending 3/28/2021, assistance from the facility in which at https://data.cms.gov/stories/s/COVID-19- they reside or from family members or 62 https://www.healthaffairs.org/doi/full/10.1377/ Nursing-Home-Data/bkwz-xpvg/. caregivers. As we currently do not hlthaff.2020.00957.

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all newly hired staff and newly uptake targets. It would also ensure we because we cannot afford sizable delay admitted residents have been vaccinated can identify and address barriers to in effectuating this IFC, we find good when they start employment or begin completing a vaccination series, such as cause to waive the 30-day delay in the residency, turnover is so high that we missed or declined second doses. effective date and, moreover, to make estimate an excess of two million If this lack of data continues, CDC this IFC effective 10 calendar days after persons may still need vaccination in will have insufficient information upon this rule is filed for public inspection in the first year after this rule takes effect. which to provide support to or revise the Federal Register. It is critically important that facilities COVID–19 infection, prevention, and In this IFC, we follow on policy are required to continue to offer control measures for LTC facilities. issued in the September 2, 2020, vaccination to their residents and staff While recommendations for routine staff COVID–19 IFC, which revised on an ongoing basis. testing could be linked to vaccination regulations to strengthen CMS’ ability to Also, we note that some individuals rates in each LTC facility (and thus enforce compliance with Medicare and declined the vaccine when it was first reduce burden on facilities with Medicaid LTC facility requirements for offered; approximately 22 percent of adequate rates of vaccine coverage), reporting information related COVID–19 LTC facility residents and 62 percent of CDC will not have enough data to assess and established a new requirement for LTC staff 63 initially declined the a change in recommendation without LTC facilities for COVID–19 testing of vaccine, but provisional CDC data full national participation in COVID–19 facility residents and staff. Since the suggest that uptake increased over time vaccination reporting by CMS-certified publication of the September IFC, the as the safety and effectiveness of the LTC facilities. FDA has issued EUAs for multiple vaccines has become better understood, Declining infection rates in LTC vaccines developed to prevent the and approaches that ameliorate vaccine facilities in early 2021 suggest that spread of SARS-CoV–2. hesitancy have been identified. For vaccination, along with implementation We anticipate evaluating public input of the full complement of non- residents and staff who overcome and evolving science before finalizing pharmaceutical interventions, including vaccine hesitancy, it is critical to their any requirements. engineering and administrative controls, health and well-being that they are able For this IFC, we believe it would be has reduced the risk of illness and death to get the vaccine when they are ready impractical and contrary to the public from COVID–19 for LTC facility to receive it. interest for us to undertake normal All of the concerns that warrant residents. Without the reporting notice and comment procedures and to immediate COVID–19 vaccination mandate, CMS will have no timely way thereby delay the effective date of this rulemaking for LTC facilities are also of monitoring whether LTC facilities are IFC. We find good cause to waive notice applicable to ICFs–IID. ICF–IID clients complying with the requirement to offer of proposed rulemaking under the APA, continue to be at high risk of serious vaccination. Further, such mandatory 5 U.S.C. 553(b)(B), and section illness from COVID–19 due to their reporting allows health care agencies 1871(b)(2)(C) of the Act. For those same participation in congregate living and and regulators to better evaluate the reasons, we find it is impracticable and must have ongoing access to the impact and importance of vaccination. contrary to the public interest not to vaccine. While there are no data Without a reporting requirement, we waive the delay in effective date of this regarding client and staff turnover rates will have no way to identify those IFC under the APA, 5 U.S.C. 553(d), in ICFs–IID, it is reasonable to assume nursing homes with low vaccination section 1871(e)(1)(B)(i) of the Act, and that staff turnover rates may be as high rates so that they can be supported by the CRA, 5 U.S.C. 801(a)(3). Therefore, as those in LTC facilities (see the RIA educational outreach and their residents we find there is good cause to waive the section of this preamble). and staff protected by vaccination. Unfortunately, we have significant delay in effective date pursuant to the C. Data for COVID–19 Vaccine data gaps about the effects of COVID–19 APA, 5 U.S.C. 553(d)(3), section Reporting: Targeting Resources and vaccination rates among ICF–IID 1871(e)(1)(B)(ii) of the Act, and the Our knowledge of the effects of clients, with fewer than 80 ICFs–IID CRA, 5 U.S.C. 808(2). COVID–19 vaccination in LTC facilities voluntarily reporting vaccination data We are providing a 60-day public comes from several sources, including through NHSN. While we recognize that comment period. reporting by Partnership pharmacies it is impractical to require ICFs–IID to IV. Collection of Information (COI) and voluntary reporting by some report COVID–19 information to NHSN Requirements facilities through NHSN. Direct immediately, we believe that voluntary vaccination reporting to encouraging voluntary reporting is a Under the Paperwork Reduction Act NHSN by LTC facilities has been very critical first step in gaining data to help of 1995, we are required to provide 30- low, with less than 20 percent of us understand the effects of the day notice in the Federal Register and facilities reporting on vaccinations pandemic on clients and staff, solicit public comment before a through NHSN. Unfortunately, we are supporting uptake of COVID–19 vaccine collection of information requirement is unable to examine the effects of in this community. submitted to the Office of Management and Budget (OMB) for review and accepting or declining participation in D. Moving Forward the Pharmacy Partnerships because the approval. In order to fairly evaluate data are incomplete for LTC facilities For the reasons discussed above, it is whether an information collection and ICFs–IID. Requiring LTC facilities to critically important that we implement should be approved by OMB, section report on resident and staff vaccination the policies in this IFC as quickly as 3506(c)(2)(A) of the Paperwork status, in conjunction with the existing possible. As the nation continues to Reduction Act of 1995 (PRA) requires COVID–19 testing data, would provide address the health impacts of COVID– that we solicit comment on the the data necessary to identify the 19, we find good cause to waive notice following issues: • outcomes of Pharmacy Partnership and comment rulemaking as we believe The need for the information participation and determine vaccine it would be impracticable and contrary collection and its usefulness in carrying to the public interest for us to undertake out the proper functions of our agency. • 63 https://www.cdc.gov/mmwr/volumes/70/wr/ normal notice and comment rulemaking The accuracy of our estimate of the mm7005e2.htm. procedures. For the same reasons, information collection burden.

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• The quality, utility, and clarity of information collection requirements fringe benefits, according to standard the information to be collected. (ICRs): HHS estimating procedures. If the total For the estimated costs contained in • Recommendations to minimize the cost after doubling resulted in .50 or the analysis below, we used data from information collection burden on the more, the cost was rounded up to the the United States Bureau of Labor affected public, including automated next dollar. If it was .49 or below, the Statistics to determine the mean hourly collection techniques. total cost was rounded down to the next wage for the positions used in this dollar. The total costs used in this We are soliciting public comments on analysis. For the total hourly cost, we analysis are indicated in the chart each of these issues for the following doubled the mean hourly wage for a 100 below. sections of this document that contain percent increase to cover overhead and

TABLE 1—TOTAL HOURLY COSTS BY POSITION

Mean Position hourly wage Total cost

LTC and ICF–IID: RN/IP ...... 64 $33.53 $67 LTC: Director of Nursing & ICF–IID: Administrator ...... 65 46.78 94 LTC: Medical Director ...... 66 84.57 169 LTC: Financial Clerk ...... 67 20.40 41

A. Long-Term Care Facilities information regarding the benefits and policies and procedures to ensure they risks and potential side effects for that are up-to-date and make any necessary 1. ICRs Regarding the Development of vaccine, before the LTC facility requests changes. We believe these activities Policies and Procedures for consent for administration of that dose. would be performed by the infection § 483.80(d)(3) The resident, resident representative, preventionist (IP), director of nursing At § 483.80(d)(3), we require that LTC and staff member must be provided the (DON), and medical director in the first facilities develop policies and opportunity to refuse the vaccine and year and the IP in subsequent years as procedures to ensure that each resident change their decision if they decide to analyzed below. and staff member is educated about the take the vaccine. Finally, the resident’s In the first year, the IP would need to COVID–19 vaccine. Specifically, before medical record includes documentation develop the policies and procedures by offering the COVID–19 vaccine, all staff that indicates, at a minimum, that the conducting research and obtaining the members and residents or resident resident or resident representative was necessary information and materials to representatives must be provided with provided education regarding the draft the policies and procedures. The education regarding the benefits and benefits and potential risk associated IP would need to work with the medical risks and potential side effects with the COVID–19 vaccine, and that director and DON to develop and associated with the vaccine. When the the resident either received the finalize the policies and procedures. For vaccine is available to the facility, each complete COVID–19 vaccine (series or the IP, we estimate that this would resident and staff member is offered single dose) or did not receive the require 10 hours initially to develop the COVID–19 vaccine unless the vaccine due to medical policies and procedures, and one hour immunization is medically contraindications or refusal. The a month thereafter to review and make contraindicated or the resident or staff estimates that follow are largely based changes or updates as needed, for a total member has already been immunized. If on upon our experience with LTC of 21 hours (10 hours initially and 1 an additional dose of the COVID–19 facilities. However, given the hour for the 11 months thereafter). vaccine that was administered, a uncertainty and rapidly changing nature According to Table 1 above, the IP’s booster, or any other vaccine needs to be of the pandemic, we acknowledge that total hourly cost is $67. Thus, for each administered, the resident, resident there will likely need to be significant LTC facility the burden for the IP would representative, and staff member must revisions over time as LTC facilities gain be 21 hours at a cost of $1,407 (21 hours be provided with the current experience with these requirements. As × $67). For the IPs in all 15,600 LTC previously discussed, we do not have facilities, the burden would be 327,600 64 Bureau of Labor Statistics. Occupational × Employment and Wages, May 2019. 29–1141 current reporting data on facility hours (21 hours 15,600 facilities) at an Registered Nurses. Accessed at https://www.bls.gov/ compliance with COVID–19 vaccination estimated cost of $21,949,200 ($1,407 × oes/current/oes291141.htm. Accessed on March 18, best practices of the kinds established in 15,600). For subsequent years, the IP 2021. this rule. We welcome comments that would need to review the policies and 65 Bureau of Labor Statistics. Occupational Employment and Wages, May 2019. 11–9111 might improve these estimates. procedures and make any updates or Medical and Health Services Managers. Nursing Based upon our experience with LTC changes to them. Hence, we estimate Care Facilities (Skilled Nursing Facilities). facilities, we believe that some of these that the IP would need 12 hours Accessed at https://www.bls.gov/oes/current/ facilities have already developed the annually (1 hour × 12 months) at a cost oes119111.htm. Accessed on February 17, 2021. × 66 Bureau of Labor Statistics. Occupational required policies and procedures. of $804 (12 hours $67). For all LTC Employment and Wages, May 2019. 29–1228 However, since we do not have any facilities, the annual burden would be Physicians, All Other; and Ophthalmologists, reliable method to make an estimate of 187,200 hours (12 × 15,600) at a cost of Except Pediatric. General Medical and Surgical $12,542,400 (15,600 × $804). Hospitals. Accessed at https://www.bls.gov/oes/ how many or what percentage of LTC current/oes291228.htm#(5). Accessed on February facilities have done so, we will base our As discussed above, the development 17, 2021. estimate for this ICR on all 15,600 LTC and approval of these policies and 67 Bureau of Labor Statistics. Occupational facilities needing to develop new procedures would also require activities Employment and Wages, May 2019. 43–3099 policies and procedures in order to by the medical director and the DON. Financial Clerks, All Others. Accessed at https:// www.bls.gov/oes/current/oes433099.htm. Accessed comply with this requirement. These Both the medical director and the DON on March 23, 2021. facilities also need to review the would need to have meetings with the

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IP to discuss the development, 2. ICRs Regarding LTC Facilities information on COVID–19 and vaccines evaluation, and approval of the policies Offering the COVID–19 Vaccine and available online. The CMS Nursing and procedures. We estimate that this Obtaining and Documenting Consent for Home COVID–19 training program has would require 4 hours for both the § 483.80(d)(3)(ii) Through (iv) five modules designed for the frontline medical director and DON. According to At § 483.80(d)(3)(i), we require that clinical staff and ten modules for Table 1 above, the total hourly cost for the facility offer the COVID–19 vaccine nursing home management staff a medical director is $169. For each LTC to each staff member and resident, when (building maintenance staff and other facility, this would require 4 hours for the vaccination is available to the support staff would not take these the medical director during the first year facility, unless the vaccine is medically particular courses). The training is at an estimated cost of $676 (4 hours × contraindicated, the resident has online, at http://QSEP.cms.gov, and is $169). For the first year, the burden already been vaccinated, or the resident summarized in a CMS press release that would be 62,400 (4 × 15,600) at an or the resident representative has can be found at https://www.cms.gov/ newsroom/press-releases/cms-releases- estimated cost of $10,545,600 ($676 × already refused the vaccine. We believe nursing-home-covid-19-training-data- 15,600). For subsequent years, the that the LTC facility will offer the urgent-call-action. In addition, both medical director might need to spend vaccine to the staff or resident at the same time the facility provides the CDC and FDA provide information on time reviewing or attending meetings to the COVID–19 vaccines online.68 69 discuss any updates or changes to the education required by § 483.80(d)(3)(ii) and (iii). We note that for LTC facilities Finally, we expect that trade policies and procedures; however, that publications and other public sources would be a usual and customary contracted with the Pharmacy Partnership, the education and offering would provide training materials that business practice. Therefore, these might complement or substitute for the activities for the medical director of the vaccine are being done by the participating pharmacy. We assume that CMS materials. We believe this associated with updating or changing this cost is about the same as the educational material would likely be the policies and procedures are exempt preceding estimates, so that the first selected by the IP. The IP would need from the PRA in accordance with 5 CFR year costs would be about the same to review the information available on 1320.3(b)(2). whether performed entirely in-house by the vaccines, determine what For the DON, we have estimated that facility staff or by pharmacy staff who information needs to be presented to the development of policies and visit the facility. staff, and gather that information as procedures would also require 4 hours. We note that the LTC facility or the appropriate for their facility’s staff. We According to the chart above, the total pharmacy would also have to offer the estimate that it would take an average of 4 hours for the IP to accomplish these hourly cost for the DON is $94. The vaccine to the staff member or resident tasks. Thus, for each LTC facility to burden in the first year for the DON in and have that staff member, resident, or meet this requirement would require 4 each LTC facility would be 4 hours at resident representative, complete × screening for any contraindication or burden hours at an estimated cost of an estimated cost of $376 (4 hours $268 (4 × $67). For all 15,600 LTC $94). The first year burden would be precautions, and for the resident to × consent to the vaccination or indicate facilities, the burden would be 62,400 62,400 hours (4 15,600) at an burden hours (4 × 15,600) at an estimated cost of $5,865,600 ($376 × refusal. These costs are not paperwork × × burden and are covered in the RIA that estimated cost of $4,180,800 (4 $67 15,600). For subsequent years, the DON 15,600 facilities). would likely need to spend time follows. As indicated in the next section, the At § 483.80(d)(3)(iii), we require that reviewing or attending meetings to facility must also ensure that the LTC facilities provide their residents or discuss any updates or changes to the provision of the education and the resident representatives with education policies and procedures; however, that resident’s decision must be documented regarding the benefits and risks and would be a usual and customary in the resident’s medical record. If there potential side effects associated with the business practice. Therefore, these is a contraindication to the resident COVID–19 vaccine. We believe that the activities for the DON associated with having the vaccination, the appropriate education provided to staff and updating or changing the policies and documentation must be made in the residents or resident representatives procedures are exempt from the PRA in resident’s chart. Documentation will be identical or virtually the same. accordance with 5 CFR 1320.3(b)(2). regarding a resident’s medical care is a Hence, we believe that it will not Therefore, for all 15,600 LTC facilities usual and customary business practice require any additional time or burden to in the first year, the estimated burden for a health care provider. Therefore, develop the educational materials for the residents and resident for this ICR would be 452,400 hours this activity is exempt from the PRA in representatives. According to (327,600 + 62,400 + 62,400) at a cost of accordance with 5 CFR 1320.3(b)(2). § 483.10(g)(3), the facility must ensure $38,360,400 ($21,949,200 + $10,545,600 3. ICRs Regarding Staff Education that information is provided to each + $5,865,600). Requirements in § 483.80(d)(3)(ii) resident in a form and manner the In subsequent years, all 15,600 LTC Through (iv) resident can access and understand, facilities would have the same burden. At § 483.80(d)(3)(ii), we require that including in an alternative format or in The burden for each LTC facility would the LTC facility provide all of its staff a language that the resident can be 12 hours at an estimated cost of $804 with education regarding the benefits (12 hours × $67) for the IP. Hence, for and potential risks of the COVID–19 68 CDC. Communication Resources for COVID–19 Vaccines. Access at https://www.cdc.gov/ all 15,600 LTC facilities, the burden vaccine. This would require that the × coronavirus/2019-ncov/vaccines/resource- would be 187,200 (12 15,600) at an LTC facility develop or choose center.html. Updated March 16, 2021. Accessed on estimated cost of $12,542,400 ($804 × educational materials for this staff March 23, 2021. 15,600). The requirements and burden training. We expect that most if not all 69 FDA. COVID–19 Vaccines. Access at https:// will be submitted to OMB under OMB www.fda.gov/emergency-preparedness-and- LTC facilities will use resources response/coronavirus-disease-2019-covid-19/covid- control number 0938–1363 (Expiration developed by other entities as there is 19-vaccines. Updated March 18, 2021. Accessed on Date 06/30/2022). a considerable amount of free March 23, 2021.

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understand. Thus, we expect that this 4. ICRs Regarding the Documentation × 12 × .5 × 15,600). We estimate that the required education would be in a Requirements in § 483.80(d)(3)(vi) and burden to the LTC facilities will be language that the resident or the (vii) similar in subsequent years due to the resident representative understands. At § 483.80(d)(3)(vi), we require that large turnover in these facilities. The Language translations for residents may the facility ensure that the resident’s requirements and burden will be be available in many facilities from staff, medical record is documented with, at submitted to OMB under OMB control and are virtually always available on a minimum, that the resident or resident number 0938–1363. demand through services, such as representative was provided education 5. ICRs Regarding the Reporting Language Line. LTC facilities are regarding the benefits and potential already required to provide information Requirements to CMS and CDC (NSHN) risks associated with the COVID–19 § 483.80(g)(1)(viii) and (ix) in an alternative format or language the vaccine and that the resident either resident or resident representative received the COVID–19 vaccine, did not Section 483.80(g)(1)(viii) requires LTC understands. Any additional costs are receive the vaccine due to medical facilities to electronically report minor and are discussed in more detail contraindications, or refused the information about COVID–19 in a in the RIA below. At § 483.80(d)(3)(iv), vaccine. This would require that a standardized format to the NHSN about we require that the LTC facility must health care provider, probably a the COVID–19 vaccine status of provide to the staff, resident, or the licensed nurse, would retrieve the residents and staff, including total resident representative, in situation resident’s medical record and document numbers of residents and staff, numbers where the vaccination process requires that the education was provided and of residents and staff vaccinated, one or more doses of vaccine, up-to-date whether the resident or resident numbers of each dose of COVID–19 information regarding the vaccine, representative had consented or refused vaccine received, COVID–19 including any changes in the benefits or the vaccine or whether the vaccine was vaccination adverse events. The LTC risks and potential side effects contraindicated. We estimate that this facility must also report the therapeutics associated with the COVID–19 vaccine, would require only a few seconds per administered to residents for treatment before requesting consent for resident, but estimate no costs as of COVID–19. administration of each additional maintaining a medical record is a usual We believe the IP would do this vaccinations. This would require that and customary business practice. weekly reporting to the NHSN, because the IP remains up-to-date on Therefore, this activity is exempt from information regarding COVID–19 the PRA in accordance with 5 CFR this reporting would require vaccines and ensures the information 1320.3(b)(2). information on the therapeutics that provided to the resident and the As discussed above in section II.A. of were administered to resident for resident representative before requesting this rule, the LTC facility would also be treatment of COVID–19. We believe this consent for the administration of each required to document that the required additional reporting would require additional dose of vaccine includes education was provided to its staff that about 30 minutes or .5 hour each week for the IP. Thus, for each LTC facility, current information on the benefits and must include the benefits and potential × potential risks associated with the risks associated with of the COVID–19 this burden would be 26 hours (.5 52 weeks) at an estimated cost of $1,742 vaccine. We believe that this activity vaccine as set forth in § 483.80(d)(3)(ii). × would require that the IP routinely Section 483.80(d)(3)(vii) sets forth that ($67 26) annually. For all LTC review CDC and FDA websites for the LTC facility must maintain facilities, the burden would be 405,600 hours (26 × 15,600) at an estimated cost updates and make any necessary documentation on its staff regarding the × changes to the education materials used education provided; that the staff person of $27,175,200 ($1,742 15,600) by the LTC facility. We estimate that was offered the COVID–19 vaccine or annually. this would require 6 hours of an IP’s information on obtaining the vaccine, Thus, the total annual burden for all time annually. Thus, for each LTC and his or her vaccine status and related LTC facilities to comply with the facility to meet this requirement would information indicated by the NSHN. requirements in this IFC in the first year require 6 burden hours at an estimated This would require that a staff person is 1,107,600 (452,400 + 62,400 + 93,600 cost of $402 (6 × $67). For all LTC document the required information in + 93,600 + 405,600) hours at an facilities, the annual burden would be the staff person’s record. We estimate estimated cost of $79,825,200 93,600 (6 hours × 15,600) hours at an that this would require one half-hour ($38,360,400 + $4,180,800 + $6,271,200 estimated cost of $6,271,200 ($402 × per month per facility. According to + $3,837,600 + $27,175,200). In 15,600). We estimate that the burden to Table 1 above, the total hourly cost of subsequent years, the burden would be the LTC facilities will be similar in a financial clerk is $41. For each LTC 780,000 hours (187,200 + 93,600 + subsequent years due to the large facility, we estimate that the burden for 93,600 + 405,600) at an estimated cost turnover in these facilities. The this activity would be 6 hours at an of $49,826,400 ($12,542,400 + requirements and burden will be estimated cost of $246 ($41 × 12 × .5). $6,271,200 + $3,837,600 + $27,175,200). submitted to OMB under OMB control For all LTC facilities, this would require See Table 2 below. The requirements number 0938–1363 (Expiration Date 93,600 (12 × .5 × 15,600) burden hours and burden will be submitted to OMB 6/30/2022). at an estimated cost of $3,837,600 ($41 under OMB control number 0938–1363.

TABLE 2—TOTAL COST FOR COI REQUIREMENTS FOR ALL LTC FACILITIES

First year Subsequent years COI requirements Burden hours Costs Burden hours Costs

§ 483.80(d)(3) Developing Policies and Procedures ...... 452,400 $38,360,400 187,200 $12,542,400 § 483.80(d)(3)(ii) & (iii) Developing education materials for staff members and residents and residents’ Representatives ...... 62,400 4,180,800 N/A N/A

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TABLE 2—TOTAL COST FOR COI REQUIREMENTS FOR ALL LTC FACILITIES—Continued

First year Subsequent years COI requirements Burden hours Costs Burden hours Costs

§ 483.80(d)(3)(iv) Keeping vaccine information up-to-date and Making nec- essary changes ...... 93,600 6,271,200 93,600 6,271,200 § 483.80(d)(3)(vi) and (vii) Documentation requirements ...... 93,600 3,837,600 93,600 3,837,600 § 483.83(d)(3)(viii) and (ix) NHSN Reporting ...... 405,600 27,175,200 405,600 27,175,200

Totals ...... 1,107,600 79,825,200 780,000 49,826,400

B. Intermediate Care Facilities for accessible format for the client and his all 5,772 ICFs–IID, the total burden for Individuals With Intellectual Disabilities or her representative. It must be in a the administrator would be 17,316 (ICF–IIDs) language that they understand and in a hours (3 × 5,772 facilities) at an format that is accessible to them, such estimated cost of $1,627,704 ($282 × 1. ICRs Regarding the Development of as Braille or large print for a person who 5,772 facilities). Policies and Procedures for is visually-impaired or in American As discussed above, the ICF–IID § 483.460(a)(4) Sign Language for a person who is administrator would need to obtain At new § 483.460(a)(4), we require hearing-impaired. The RN would need approval from the ICF–IID’s governing that ICFs–IID develop policies and to work with an ICF–IID administrator board for the policies and procedures. procedures to ensure that each client or who would likely provide input and Since the review and approval of client’s representative and staff member guidance in developing the policies and policies and procedures should be is educated about the COVID–19 procedures and would need to approve encompassed within the governing vaccine. Specifically, before offering the them before they go before the board’s responsibilities, this activity COVID–19 vaccine, all staff members governing body for approval. For the would be usual and customary and and clients or client representatives RN, we estimate that this would require exempt from the information collection must be provided with education 5 hours initially, and 30 minutes or .5 estimate. In addition, in subsequent regarding the benefits and risks and hour a month thereafter to review for years the ICF–IID administrator might potential side effects associated with the updated information to determine if any need to spend time reviewing or vaccine. When the vaccine is available changes need to be made to the policies attending a meeting to discuss any to the facility, each client and staff or procedures and then make any updates to the policies and procedures; member is offered COVID–19 vaccine necessary changes. According to Table 1 however, that would also be a usual and unless the immunization is medically above, the total hourly cost for an RN is customary business practice. Therefore, contraindicated or the client or staff $67. We estimate that for each ICF–IID, this activity is exempt from the PRA in member has already been immunized. If the burden would be 10.5 hours (5 accordance to 5 CFR 1320.3(b)(2). an additional dose of the COVID–19 hours initially + 5.5 (11 × .5)) for the RN Therefore, for all ICFs–IID, the total vaccine that was administered, a during the first year at an estimated cost annual burden in the first year for the booster, or any other vaccine needs to be of $704 ($67 × 10.5 hours). Assuming required policies and procedures would administered, the client, client 5,772 ICFs–IID, for the first year the be 77,922 burden hours (60,606 + representative, and staff member must burden for all facilities would be 60,606 17,316) at an estimated cost of $5,688,306 ($4,060,602 + $1,627,704). In be provided with the current burden hours (10.5 × 5,772 facilities) at subsequent years, the burden would information regarding the benefits and an estimated cost of $4,060,602 (10.5 × only be for the RN and it would be risks and potential side effects for that $67 × 5,772). In subsequent years, the 34,632 burden hours at an estimated vaccine, before the ICF–IID requests burden for this activity for each facility cost of $2,320,344. The requirements consent for administration of that dose. would be 6 hours (.5 hour × 12 months) and burden will be submitted to OMB The client, client’s representative, and at an estimated cost of $402 (6 × $67). under OMB control number 0938-New. staff member must be provided the In subsequent years the burden for all opportunity to refuse the vaccine and facilities would be 34,632 (6 × 5,772) 2. ICRs Regarding the ICFs–IID Offering change their decision if they decide to burden hours at an estimated cost of the Vaccine and Obtaining and take the vaccine. Finally, the client’s $2,320,344 (6 × $67 × 5,772). Documenting Consent in medical record must include For the ICF–IID administrator, we § 483.460(a)(4)(i) documentation that indicates, at a believe it would require 3 hours to work At new § 483.460(a)(4)(i), we require minimum, that the client or client’s with the RN in developing the policies that the ICF–IID offer the COVID–19 representative was provided education and procedures and give final approval vaccine to each staff member and client, regarding the benefits and risks and before taking the policies and when the vaccination is available to the potential side effects of the COVID–19 procedures to the governing body for facility, unless the vaccine is medically vaccine and each does of the COVID–19 approval. We believe that the contraindicated, the client has already vaccine administered to the client or if administrator would likely make a been vaccinated, or the client or the the client did not receive a dose due to salary similar to that of a manager in the client representative has already refused medical contraindications or refusal. LTC setting, like that for the DON salary the vaccine. We believe that the ICF–IID We believe that developing these as discussed above. Therefore, we will offer the vaccine to the client or the policies and procedures would require a estimate that an ICF–IID administrator’s client representative at the same time RN to gather the necessary information hourly mean salary is about $94. Thus, the facility provides the education and materials and draft the policies and for each ICF–IID, the burden hours for required by new § 483.460(a)(4)(ii). This procedures. The facility must also the administrator would be 3 hours at activity would require that the ICF–IID ensure that these materials are in an an estimated cost of $282 (3 × $94). For offer the vaccine to the staff member or

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resident and have that staff member, RN. The RN would need to review the minimum, that the client or client’s client, or client representative complete information available on the vaccines, representative was provided education screening for any contraindication or determine what information needs to be regarding the benefits and potential precautions, and for the client or client presented to the client, client’s risks associated with the COVID–19 representative consent to the representative and staff members, and vaccine and that the resident either vaccination or indicated refusal. This is gather that information as appropriate. received the COVID–19 vaccine or did not a paperwork burden and are covered An ICF–IID administrator would likely not receive the vaccine due to medical in the RIA that follows. work with the RN and need to approve contraindications, or refused the the final educational material. We 3. ICRs Regarding the Education vaccine. This would require that the RN estimate that it would initially require 7 Requirements in § 483.460(a)(4)(ii), (iii), to retrieve the client’s medical record hours and thereafter 6 hours annually to and (iv) and document the required information. review for updates and make those At new § 483.460(a)(4)(ii), we require changes to the educational materials for We estimate that this would require that the ICF–IID provide all of its staff a total of 13 hours for the RN to only a few seconds per client but with education regarding the benefits accomplish these tasks in the first year. estimate no costs as maintaining a and potential risks associated with of Thus, for each ICF–IID, the burden for medical record is a usual and customary the COVID–19 vaccine. New the RN would require 13 burden hours business practice. Therefore, this § 483.460(a)(4)(iii) requires that the ICF– at an estimated cost of $871 (13 × $67). activity is exempt from the PRA in IIF to provide each client or the client’s For all 5,772 ICFs–IID so the burden for accordance with 5 CFR 1320.3(b)(2). representative education regarding the all facilities would be 75,036 burden At new § 483.460(f), the ICF–IID is × benefits and risks and potential side hours (13 hours 5,772 facilities) at an required to, at a minimum, document effects associated with the vaccine. In estimated cost of $5,027,412 (5,772 that their staff were provided education addition, new § 483.460(a)(4)(iv) × hours $871). regarding the benefits and potential requires that the ICF–IID, in situations For the education required in risks associated with the COVID–19 where there is an additional dose of the subsequent years, the RN would need to vaccine and that each staff member was COVID–19 vaccine that was ensure that the information regarding administered, a booster, or any other COVID–19 vaccines that is provided to offered the vaccine or was provided vaccine needs to be administered, must the staff, client and the client’s information on how to obtain it. This provide the client, client’s representative before requesting consent would require that a staff person representative, and staff member with for each additional dose of the vaccine document that these tasks were the current information regarding the is current. We believe that this activity accomplished. We estimate that this benefits and risks and potential side would require the RN to routinely would require one quarter or 0.25 hour effects for that vaccine, before the review CDC and FDA websites for per month per facility and that this task facility requests consent for updates and make any necessary would be performed by administrative administration of that dose. We believe changes to the education materials used staff, probably a financial clerk. that all of the education provided by the by the ICF–IID. We estimate that this According to Table 1 above, the total ICF–IID to the client, client’s would require 6 hours of an IP’s time hourly cost for a financial clerk of $41. representative and the staff would be annually. Thus, for each ICF–IID to meet For each ICF–IID it would require 3 virtually identical. this requirement would require 6 hours annually (0.25 × 12) at an For the initial education, the ICF–IID burden hours at an estimated cost of estimated cost of $123 ($41 × 3 hours). would be required to develop × $402 ($67 6 hours). For all ICFs–IID, For all ICFs–IID, the documentation educational materials by reviewing meeting this requirement would require requirements in this IFC this would available resources on COVID–19 34,632 burden hours (6 hours × 5,772 × vaccines. We expect that most if not all require 17,316 burden hours (3 hours facilities) at an estimated cost of 5,772 facilities) at an estimated cost of ICFs–IID will use resources developed $2,320,344 (5,772 × $402). The $709,956 annually (17,316 hours × by other entities as there is a requirements and burden will be $123). considerable amount of free information submitted to OMB under OMB control on COVID–19 and its vaccines available number 0938-New. In total, we estimate that information online. For example, CDC and FDA collection burden for all ICFs–IID would 4. ICRs Regarding the Documentation provide information on the COVID–19 be about 170,274 hours and $11,425,674 Requirements in § 483.460(a)(4)(vi) and vaccines online.70 71 Finally, we expect in the first year and 86,580 hours and (f) that trade publications and other public $5,350,644 in subsequent years. sources would provide training At new § 483.460(a)(4)(vi), the ICF– materials. We believe this educational IID must ensure that the client’s medical material would likely be selected by the record is documented with, at a

TABLE 3—TOTAL BURDEN FOR COI REQUIREMENTS FOR ALL ICFS–IID

First year Subsequent years COI requirement Burden hours Costs Burden hours Costs

§ 483.460(a)(4) Developing the policies and procedures ...... 77,922 $5,688,306 34,632 $2,320,344 § 483.460(a)(4)(ii), (iii), and (iv) Education requirements ...... 75,036 5,027,412 34,632 2,320,344 § 483.460(a)(4)(v) and (f) Documentation requirements ...... 17,316 709,956 17,316 709,956

Totals ...... 170,274 11,425,674 86,580 5,350,644

70 See FN#71. 71 See FN#72.

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The total burden estimate for the $91,250,874 ($79,825,200 + The requirements and burden will be information collection burden in both $11,425,674) and in subsequent years submitted to OMB under OMB control LTC facilities and ICFs–IID in the first the burden is estimated at 866,580 hours number 0938–1363 for the LTC facilities year is 1,277,874 hours (1,107,600 + (780,000 + 86,580) at a cost of and 0938-New for the ICFs–IID. 170,274) at an estimated cost of $55,177,044 ($49,826,400 + $5,350,644).

TABLE 4—TOTAL COI BURDEN FOR LTC FACILITIES AND ICFS–IID IN THIS IFC

First year Subsequent years Type of facility Burden hours Costs Burden hours Costs

LTC Facility ...... 1,107,600 $79,825,200 780,000 $49,826,400 ICFs–IID ...... 170,274 11,425,674 86,580 5,350,644

Totals ...... 1,277,874 91,250,874 866,580 55,177,044

If you comment on this information current regulations, which are silent on the principles set forth in the Executive collection requirements, that is, the subject of vaccination to prevent order. reporting, recordkeeping or third-party COVID–19. A regulatory impact analysis (RIA) disclosure requirements, please submit B. Overall Impact must be prepared for major rules with your comments electronically as economically significant effects ($100 specified in the ADDRESSES section of We have examined the impacts of this million or more in any 1 year). We this interim final rule. rule as required by Executive Order estimate that this rulemaking is Comments must be received on/by 12866 on Regulatory Planning and June 14, 2021. ‘‘economically significant’’ as measured Review (September 30, 1993), Executive by the $100 million threshold, and V. Response to Comments Order 13563 on Improving Regulation hence also a major rule under the and Regulatory Review (January 18, Because of the large number of public Congressional Review Act. Accordingly, 2011), the Regulatory Flexibility Act we have prepared an RIA that, taken comments we normally receive on (RFA) (September 19, 1980, Pub. L. 96– together with COI section and other Federal Register documents, we are not 354), section 1102(b) of the Social sections of the preamble, presents to the able to acknowledge or respond to them Security Act, section 202 of the individually. We will consider all best of our ability the costs and benefits Unfunded Mandates Reform Act of 1995 comments we receive by the date and of the rulemaking. (March 22, 1995; Pub. L. 104–4), time specified in the DATES section of Executive Order 13132 on Federalism This RIA focuses on the overall costs this preamble, and, when we proceed (August 4, 1999) and the Congressional and benefits of the rule, taking into with a subsequent document, we will Review Act (5 U.S.C. 804(2)). account vaccination progress to date or respond to the comments in the anticipated over the next year that is not preamble to that document. Executive Orders 12866 and 13563 direct agencies to assess all costs and due to this rule, and estimating the VII. Regulatory Impact Analysis benefits of available regulatory likely additional effects of this rule. We analyze both the costs of the required A. Statement of Need alternatives and, if regulation is necessary, to select regulatory actions and the payment of those costs. The COVID–19 pandemic has approaches that maximize net benefits As intended under these requirements, precipitated the greatest economic crisis (including potential economic, this RIA’s estimates cover only those since the Great Depression, and one of environmental, public health and safety costs and benefits that are likely to be the greatest health crises since the 1918 effects, distributive impacts, and the effects of this rule. In the case of the Influenza pandemic. Of the equity). Section 3(f) of Executive Order COVID–19 PHE, there is rapid and approximately 540,000 Americans 12866 defines a ‘‘significant regulatory massive improvement through estimated to have died from COVID–19 vaccination, social distancing, 72 action’’ as an action that is likely to through March 2021, over one-third result in a rule: (1) Having an annual treatment, and other efforts already are estimated to have died during or underway, and this rule would have 73 effect on the economy of $100 million after a nursing home stay. The or more in any 1 year, or adversely and relatively small effects compared to development and large-scale utilization materially affecting a sector of the these other efforts, past, present, and of vaccines to prevent COVID–19 cases economy, productivity, competition, future. There are also a number of and have the potential to end future jobs, the environment, public health or unknowns that may affect current COVID–19-related nursing home deaths. safety, or state, local, or tribal progress or this rule or both. There are But this huge achievement depends governments or communities (also many unknowns (for example, whether critically on success in vaccination of referred to as ‘‘economically vaccine protection lasts only one year nursing home residents and staff. This significant’’); (2) creating a serious rather than 3 years or more, and the interim final rule will close a gap in inconsistency or otherwise interfering possibility of variants that reduce the with an action taken or planned by effectiveness of currently approved 72 https://covid.cdc.gov/covid-data-tracker/ #datatracker-home. another agency; (3) materially altering vaccines) and we cannot estimate the 73 For updated data, see CDC daily updates of the budgetary impacts of entitlement effects of each of the possible total deaths at https://www.cdc.gov/nchs/nvss/vsrr/ grants, user fees, or loan programs or the interactions among them, but COVID19/index.htm, and the Kaiser Family rights and obligations of recipients throughout the analysis we point out Foundation weekly updates on nursing home some of the most important assumptions deaths at https://www.kff.org/coronavirus-covid-19/ thereof; or (4) raising novel legal or issue-brief/state-covid-19-data-and-policy-actions/, policy issues arising out of legal we have made and the possible effects among other sources. mandates, the President’s priorities, or of alternatives to those assumptions.

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This rule presents additional second large cluster of costs are for the person left each day and was replaced difficulties in estimating both costs and required resident, client, and staff that same day by another person. benefits due primarily to the fact that an education. In addition, we are requiring In Table 5, we assume it is likely that unknown but significant fraction of facilities to offer COVID–19 vaccines to about 80 or 90 percent of LTC facility current LTC staff and residents have residents, clients, and staff. residents at the beginning of the year, already received an explanation of the As documented subsequently in this and 60 or 70 percent of the LTC facility benefits of vaccination to persons who analysis and in a research report on this staff at the beginning of the year, were are elderly or high risk from specific issue, about 1.5 million individuals vaccinated by the end of March, due health conditions or both, and the rarely work in nursing facilities at any one mainly to the efforts of the Partnership. serious risks associated with time.77 These individuals are at high But there are many new persons in each vaccination (for example, the risk both to become infected with category during the first three months statistically negligible risk of severe COVID–19 and to transmit the SARS– (one fourth of the annual number shown allergic reactions to the vaccine). For a CoV–2 virus to residents or visitors. Far in the second column) and likely fewer statistically average LTC resident, the more than most occupations, nursing of these will have been vaccinated average pre-COVID life expectancy if home care requires sustained close elsewhere. Hence, we assume that the death occurs while in the facility is contact with multiple persons on a daily percent of persons who were vaccinated likely to be on the order of 3 years or basis. by the end of March is only 70 percent fewer but taking into account those who In Table 5, we present estimates of of long-term care residents, 40 percent recover and leave the facility and those total numbers of individuals in the of skilled nursing care residents, and 60 enrolled for skilled nursing services we categories regulated under this rule, percent of the LTC facility staff serving estimate overall life expectancies to be distinguishing among long-term and both types of residents. The estimated about 5 years.74 We also estimate that shorter-term nursing facility residents, numbers for ICFs–IID are lower because vaccination reduces the chance of residents and staff, and numbers at the few residents or staff were eligible for infection by about 95 percent, and the beginning of a year and at any one time vaccination from any source other than risk of death from the virus to a fraction during the year, versus the much higher the Partnership in the first three months of 1 percent.75 (In Israel, of the first 2.9 numbers when turnover is taken into of the year. The estimated numbers of million people vaccinated with two account. In this table we assume that the ICF–IID residents and staff, and doses there were only about 50 number departing each year is the same turnover rates, are particularly rough infections involving severe conditions as the number entering each year, which estimates since there are no published resulting from the virus after the 14th is a reasonable approximation to sources that we have found that contain day and of these so few deaths that they changes in just a few years, but do not such estimates. We assume that staff were not reported in statistical take account of the aging of the turnover is about as high as in LTC summaries. These data also show that population over time. facilities, but that resident turnover is vaccine effectiveness rates are very high These figures are approximations, considerably lower since resident for both older and younger recipients. because none of the data that is mortality is not a major factor. Of those receiving the second vaccine routinely collected and published on The estimate that 53 percent of these dose, after the 14th day 46 people over resident populations or staff counts LTC facility and ICF–IID populations as the age of 60 became infected and had focus on numbers of individuals of the end of March were actually a severe case, compared to 6 people residing or working in the facility vaccinated is simply a weighted average under the age of 60. Two million nine during the course of a year or over time. of these numbers. The second and third hundred thousand (2.9 million) people Depending on the average length of stay sections of Table 5 show how these received a second dose; therefore both (that is, turnover) in different facilities, numbers are split between residents and rates are near zero.) 76 an average population at any one time staff, and LTC facilities and ICFs–IID, of, for example, 100 persons would be respectively. This table estimates that C. Anticipated Costs of the Interim Final consistent with radically different during the first year after the issuance Rule numbers of individuals, such as 112 of this regulation, as many people will The previously calculated information individuals in one facility if one person be candidates for vaccination in these collection costs of this rule are one of left each month and was replaced by facilities as during the first three months three major categories of cost. The another person, compared to 365 if one of calendar year 2021 (see last column). TABLE 5—ESTIMATES OF NUMBER AND VACCINATION STATUS OF RESIDENTS AND STAFF [Thousands]

Remaining New Beginning New during Total Percent Number vaccination candidates Total of year 2021 for 2021 vaccinated vaccinated candidates 1st quarter first year 2021* by March 31 by March 31 2021 2022 candidates **

Long-Term Care Residents ...... 1,200 400 1,600 70 1,120 480 100 580 Skilled Nursing Care Residents ...... I 200 I 2,100 I 2,300 I 40 I 920 I 1,380 I 525 I 1,905

74 At age 80, the average life expectancy of a male ‘‘When you’re 83, It’s not going to be 20 years,’’ ’’ ‘‘BNT162b2 mRNA Covid–19 Vaccine in a is about 8 years and of females about 10 years, or JAMA, Dec. 23, 2009, 2686–2694. Nationwide Mass Vaccination Setting,’’ The New an overall average of about 9 years. Long-term care 75 For patients in skilled nursing facilities, England Journal of Medicine, 2/24/2021, at https:// nursing home residents, however, have shorter life average length of stay is less than a month. Hence, www.nejm.org/doi/full/10.1056/NEJMoa2101765. expectancies because they have severe health turnover is far higher. 77 Kaiser Family Foundation, COVID–19 and problems or would not have been admitted to a 76 facility. For those who die while in a facility the See Dvir Aran, Estimating real-world COVID– Workers at Risk: Examining the Long-Term Care average life expectancy is about two years. But 19 vaccine effectiveness in Israel using aggregated Workforce, April 23, 2020, at https://www.kff.org/ some recover and leave so we have used five years counts, medRxiv, February 28, 2021, at https:// coronavirus-covid-19/issue-brief/covid-19-and- as a reference point. See discussion at David B. www.medrxiv.org/content/10.1101/2021.02. workers-at-risk-examining-the-long-term-care- Reuben, ‘‘Medical Care for the Final Years of Life: 05.21251139v3.full.pdf and Noa Dagan et al., workforce/.

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TABLE 5—ESTIMATES OF NUMBER AND VACCINATION STATUS OF RESIDENTS AND STAFF—Continued [Thousands]

Remaining New Beginning New during Total Percent Number vaccination candidates Total of year 2021 for 2021 vaccinated vaccinated candidates 1st quarter first year 2021* by March 31 by March 31 2021 2022 candidates **

LTC Facility Staff ...... 950 760 1,710 60 1,026 684 190 874 ICF–IID Residents ...... 100 20 120 20 24 96 5 101 ICF–IID Staff ...... 75 60 135 20 27 108 15 123

Total Persons ...... 2,525 3,340 5,865 53 3,117 2,748 835 3,583

Residents Total ...... 1,500 2,520 4,020 51 2,064 1,956 630 2,586 Staff Total ...... 1,025 820 1,845 57 1,053 792 205 997

Total Persons ...... 2,525 3,340 5,865 53 3,117 2,748 835 3,583

LTC Facility Total ...... 2,350 3,260 5,610 55 3,066 2,544 815 3,359 ICF–IID Total ...... 175 80 255 20 51 204 20 224

Total Persons ...... 2,525 3,340 5,865 53 3,117 2,748 835 3,583 * Beginning of Year is roughly identical to average for year when population is stable. ** Estimated number potentially needing vaccination in the first full year after March 31st.

As presented in the third numeric in group settings and some education Information Collection analysis. As for column of Table 5, the total number of will take place on a one-to-one level. the recipients of such education, we individuals either residing or working What works best will depend on the assume that about three-fourths of them in all of these different facilities over the circumstance of the resident and the are residents, and one-fourth staff. We course of a year is about 5.9 million best method for conveying the have little data on resident income but persons, which is more than twice the information and answering questions. know that for most, Social Security or annual average number of residents or Staff can use opportunities during Supplemental Security Income are their staff shown in the first numeric column. normal day-to-day activities to educate principal sources of income.79 For A new study, using data from detailed the residents and their representatives estimating purposes, we assume that payroll records, found that median (if they are present) on the their time is worth about $10.02 an hour turnover rates for all nurse staff are immunization opportunities through the (median income of older adults without approximately 90 percent a year.78 Due facility or its partners. Staff education, earnings is $20,440 annually.80 Since to these high turnover rates, LTC using CDC or FDA materials, can also residents are rarely in the labor market facilities will require significantly more take place in various formats and ways. while in the facility, this base income resident or staff vaccines compared to Individualized counseling, resident has not been adjusted for fringe benefits the total number of residents and staff meetings, staff meetings, posters, or employer expenses. For staff, we in the facility at the beginning of the bulletin boards, and e-newsletters are all estimate hourly costs of $27.38 based on year. For example, when the Pharmacy approaches that can be used to provide BLS data for healthcare support Partnership completed its time education. Informal education may also occupations (median of $13.69, doubled commitment in LTC facilities, it occur as staff go about their daily duties, to account for fringe benefits and probably had seen only about half of the and some who have been vaccinated overhead). persons who will reside or work in may promote vaccination to others. We note that very little of this cost is these facilities in 2021. Of course, most Facilities may find that reward likely to involve translation of of these persons will have been techniques, among other strategies, may documents, simply because very few vaccinated through other means when help. In particular, the value of documents are involved, and electronic they enter the facilities during the immunization as a crucial component of and other assistance methods are so remainder of 2021. That said, it is likely keeping residents healthy and well is widespread. The vaccine information that there will be over one million already conveyed to staff in regard to Fact Sheet required by FDA to be made residents and staff during the first year influenza and pneumococcal vaccines. available is already translated by FDA after this rule is published who will The COVID–19 vaccine education will into the eight most common non- need vaccination. Much of the build upon that knowledge. English languages in use in the United immediate need for LTC resident and The techniques for education and States and is downloadable online. (For staff education has already been shared decision-making, where the Moderna vaccine, for example, see accomplished through the Pharmacy appropriate, are so numerous and varied https://www.modernatx.com/ Partnership for Long-Term Care that there is no simple way to estimate covid19vaccine-eua/providers/ Program. Even after the end of this likely costs. Staff and resident hesitancy language-resources.) LanguageLine or program, remaining unvaccinated may and likely will change over time as similar services are always available on residents and staff will benefit from the benefits of vaccination become clear call if needed for an oral explanation of additional education, especially as to increasing numbers of participants in 79 Only about 13% have private sources of additional information about vaccine congregate settings. For purposes of safety and effectiveness is available. payment. See Jose Ness et al., ‘‘Demographics and estimation, we assume that, on average, Payment Characteristics of Nursing Home Residents Some resident education can take place 30 minutes of staff time will be devoted in the United States: A 23-Year Trend,’’ Journal of to education of each unvaccinated Gerontology: MEDICAL SCIENCES, 2004, Vol. 59A, 78 Ashvin Gandhi et al., ‘‘High Nursing Staff No. 11, pp. 1213–1217. Turnover In Nursing Homes Offers Important resident, resident representative, or staff 80 Average income from Federal Reserve of St. Quality Information,’’ Health Affairs, March 2021, person, at the same average hourly cost Louis at https://fred.stlouisfed.org/series/ pages 384–391. of $67.06 estimated for RNs in the MEPAINUSA672N.

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a written document to someone who Taken together, these estimates for first year, calculated from the 70 percent does not speak English. Many computer both residents and staff suggest that (staff) to 80 percent (residents and and phone applications (‘‘Apps’’) total counseling and education efforts clients) baseline likely to be achieved providing oral translations are available would be made for perhaps 849,000 before this rule takes effect, total to assist those with language or vision persons after the rule is issued, two- vaccination costs across these target problems, and hearing problems create thirds residents and one-third staff. groups resulting from this rule would be no document translation requirements if Some of those offers would be accepted $23,460,000 ($80 × .05 × 5,865,000). a document in the reading language of and some declined (these figures do not Finally, there is a cost category related that resident is available.81 include offers made to persons already to expenses not estimated as If we assume that 20 percent of vaccinated but do include those newly residents and clients in LTC facilities admitted to or hired by these facilities). information collection costs because and ICFs–IID decline vaccination, taking Total cost of the educational efforts they meet an exception in the PRA for account of both those offered and themselves would be approximately requirements that would be handled declining the vaccine before this rule $28,442,000 (849,000 persons × .5 hours through ‘‘usual and customary’’ takes effect and those offered it again in × $67 hourly cost). Cost of resident time business practices. These exceptions are the first year, 930,000 additional to participate would be an additional all discussed briefly in the ICR section vaccination counseling and education $2,449,000 (849,000 persons × .667 × .5 of this preamble. Most of their costs are efforts would be made to residents hours × $8.65 hourly cost) and of staff related mainly to recording in patient or (4,020,000 including 630,000 in the first time to participate an additional personnel records for each resident and quarter of 2022 for a total of 4,655,000 $1,631,000 (849,000 persons × .333 × .5 staff person that vaccine education, total individual residents × .2). This hours × $27.38 hourly costs). Second- vaccine decision, and vaccinations for figure implicitly assumes that a much and third-year totals would be lower, those accepting vaccination have all higher take-up rate was achieved during perhaps about three-fourths as much, taken place. While there are large the first three months of 2021, likely taking into account both fewer numbers of such record notations to be about 80 to 90 percent of all those remaining unvaccinated needing these made, we estimate that they take only a residents reached by Pharmacy Partners efforts, and a sensible reduction in few seconds per record. We have and other early vaccination efforts, and efforts aimed at persons who refuse to estimated that the added cost of these that there will be more and more varied consider vaccination. Hence, total cost record-keeping functions as likely to be effort needed for the remainder, most of of these educational efforts to both about 5 percent of all Information whom presumably declined the initial educators and recipients would be a Collection costs. offer. It also assumes that only about total of $35,220,000 in the first year and All these aggregate costs can be half of year-end residents will have been $26,415,000 in the second and third converted to per person numbers since vaccinated when this rule is issued even years. it is individual persons who are though most residents at the beginning The third major cost component is the vaccinated. Dividing the estimated first of the year will have been vaccinated. vaccination, including both year costs by an estimated 5.380 million Hence, there will be about 517,000 administration and the vaccine itself. people (4.02 million residents and 1.36 residents needing vaccine education We estimate that the average cost of a million workers) gives an average per and offers needed to be made in the first vaccination is what the Government resident or employee cost of $27.12 in full year (20 percent of rightmost pays under Medicare: $20 × 2 = $40 for the first year (159,056,000 divided by Residents Total column of Table 5). two doses of a vaccine, and $20 × 2 for 5,865,000). For education of staff, we make vaccine administration of two doses, for similar assumptions, except that early a total of $80 per resident. This estimate Another way to summarize these and anecdotal evidence suggests that a is made for simplicity, ignoring newer numbers is in terms of average cost per third or more are declining and one-dose vaccines, since the great person newly vaccinated. Making the vaccination.82 This means that about an majority of recipients are Medicare same assumption that about 5 percent of additional 332,000 (one-third of beneficiaries and we have no data yet on total persons (and 10 percent of those 997,000) vaccination counseling and likely use of newer vaccines.83 unvaccinated) would be newly education efforts will need to be made Assuming that the efforts to educate vaccinated as a result of this rule, cost to staff, including new hires, in the residents, clients, and staff succeed in per person would be $542 ($27.12 remainder of 2021 and the first quarter raising the vaccinated percentage by 5 divided by .05). Table 6 summarizes the of 2022. percent points over the course of the overall cost estimates.

TABLE 6—ESTIMATE OF TOTAL COSTS

Costs in Cost category Costs in succeeding first year years

Developing NF Policies & Procedures ...... $38,360,000 $12,542,000 Developing Education Materials for Residents and Staff ...... 4,181,000 NA Keeping Vaccine Information Up-to-Date ...... 6,271,000 6,271,000 Documentation Requirements ...... 3,838,000 3,838,000

81 Examples of translation Apps include Google www.kff.org/coronavirus-covid-19/dashboard/kff- for all drugs, cost estimates also vary depending on Translate, iTranslate Voice 3, SayHi, TextGrabber, covid-19-vaccine-monitor/. research and development costs as well as BrailleTranslater, and many more. 83 Vaccine and vaccination costs are generally manufacturing cost. These estimates do not reflect 82 The Kaiser Family Foundation estimates as of paid by the Federal Government. What the use of the new Johnson & Johnson/Jannsen one-dose Government pays varies from vaccine to vaccine, by February 22 that to date 37 percent of all health care vaccine. See the Healthline article at https:// when purchased and in what quantities, and varies www.healthline.com/health-news/how-much-will- workers (not specific to LTC workers) have declined by payer or provider. $40 per dose is a rough vaccination or decided to wait and see. See https:// estimate based on experience to date. As is the case it-cost-to-get-a-covid-19-vaccine.

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TABLE 6—ESTIMATE OF TOTAL COSTS—Continued

Costs in Cost category Costs in succeeding first year years

NHSN Reporting to CDC and CMS ...... 27,175,000 27,175,000 Subtotal, NF Information Collection ...... 79,825,000 49,826,000 ICF–IID Information Collection ...... 11,426,000 5,351,000 Subtotal Information Collection ...... 91,251,000 55,177,000 Educating Residents & Staff * ...... 35,220,000 26,415,000 Providing Vaccine to Residents and Staff ** ...... 23,460,000 17,595,000 Keeping Records of the Above Activities ...... 9,125,000 5,518,000

Total Costs ...... 159,056,000 104,705,000 * These costs assume only unvaccinated are educated about vaccination. ** These costs assume about 5 percent of total persons accept the vaccine offer (over half already vaccinated).

While these estimates give the vaccinated.85 Reductions in resident, should the assumptions be overtaken by appearance of precision since they client, and staff mortality are benefits adverse events. present costs to the nearest thousand for which techniques exist (though with The HHS ‘‘Guidelines for Regulatory dollars, this is simply the result of some uncertainty) to express estimates Impact Analysis’’ explain in some detail calculations based on numerical in dollar terms. One of the major the concept of Quality Adjusted Life assumptions. There are major benefits of vaccination is that it lowers Years (QALYs).87 QALYs, when uncertainties in these estimates. One the cost of treating the disease among multiplied by a monetary estimate such obvious example is whether vaccine those who would otherwise be infected as the Value of a Statistical Life Year efficacy will last more than the six and have serious morbidity (VSLY), are estimates of the value that months proven to date.84 Presumably, consequences. The largest part of those people are willing to pay for life- re-vaccination each year could maintain costs is for hospitalization and they are prolonging and life-improving health a high level of protection if vaccine very substantial. As discussed later in care interventions of any kind (see protection wore off in a year. Re- the analysis we do have data on the sections 3.2 and 3.3 of the HHS vaccination or use of new and improved average costs of hospitalization of these Guidelines for a detailed explanation). patients (it is, however, unclear as to vaccines would likely maintain the The QALY and VSLY amounts used in how that cost is changing over time with effectiveness of vaccination for residents any estimate of overall benefits are not better treatment options). A lesser but meant to be precise, but instead are and staff. But the estimated costs of this still very substantial amount of these rough statistical measures that allow an rule would change in the table column morbidity costs is for care of gravely ill overall estimate of benefits expressed in for succeeding years to a level roughly patients within the nursing home, but dollars. equal to the first year estimate even if reducing those costs is another benefit Under a common approach to benefit re-vaccinations were to be necessary. we are unable to estimate at this time. calculation, we can use a Value of a For purposes of displaying the known There is a potential offset to benefits Statistical Life (VSL) to estimate the second (and succeeding) year effects that we have not estimated. As long as dollar value of the life-saving benefits of assuming no major changes in vaccine vaccine supplies do not meet all a policy intervention, such as this rule. effectiveness, we have included in Table demands for vaccination, giving priority We adopt the VSL of approximately 5 (and the tables covering information to some persons over others necessarily $10.6 million in 2020 as described in collection costs) the predictable changes means that some persons will become the HHS Guidelines, adjusted for in second year cost estimates. infected who would not have been changes in real income and inflated to infected had the priorities been D. Anticipated Benefits of the Interim 2019 dollars using the Consumer Price reversed. In this case, however, the Final Rule Index. Assuming that the average rate of priority for elderly persons (virtually all death from COVID–19 (following SARS– There will be over 5 million residents, of whom have risk factors) who CoV–2 infection) at nursing home clients, and staff each year in the LTC comprise the vast majority of LTC resident ages and conditions is 5 facilities and ICFs–IID covered by this facility residents, is prioritizing those at percent, and the average rate of death rule. In our analysis of first-year benefits higher risk of mortality and severe after vaccination is essentially zero, the of this rule we focus on prevention of disease over those whose risk of death expected value of each resident 86 death among residents of LTC facilities is multiple orders of magnitude lower. receiving the full course of two vaccines and ICFs–IID, as well as on progress in As a result, there are some assumptions who would otherwise be infected with reducing disease severity. We also focus we make that could overstate benefits SARS–CoV–2 is about $530,000 × only on benefits to the candidates for ($10,600,000 .05). 85 We note that as of this writing there remains vaccination covered by this rule, not on Under a second approach to benefit a major unanswered question as to whether and if calculation, we can estimate the possible benefits to family members, so to what extent vaccinated persons transmit caregivers, or other persons who they COVID–19. monetized value of extending the life of might subsequently infect if not 86 The risk of death from infection from an nursing home residents, which is based unvaccinated 75 to 84 year old person is 320 times on expectations of life expectancy and more likely than the risk for an 18- to 29-years old the value per life-year. As explained in 84 For a discussion of this issue, see Sumathi person. CDC, ‘‘Risk for COVID–19 Infection, Reddy, ‘‘How Long To Covid–19 Vaccines Protect Hospitalization, and Death by Age Group’’, at the HHS Guidelines, the average You?’’, The Wall Street Journal, April 13, 2021, at https://www.cdc.gov/coronavirus/2019-ncov/covid- https://www.wsj.com/articles/how-long-do-covid- data/investigations-discovery/hospitalization- 87 https://aspe.hhs.gov/pdf-report/guidelines- 19-vaccines-provide-immunity-11618258094. death-by-age.html. regulatory-impact-analysis.

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individual in studies underlying the year far higher than point in time or than years.92 The annual turnover in VSL estimates is approximately 40 years average counts (see Table 5). this group is such that about 2.3 million of age, allowing us to calculate a value We do know that large numbers of residents are served each year. There is per life-year of approximately $540,000 residents or staff were vaccinated some overlap between these two and $900,000 for 3 and 7 percent through the Pharmacy Partnership, populations and the same person may discount rates respectively. This which for nursing home residents relied be admitted on more than one occasion. estimate of a value per life-year most heavily on the CVS and Walgreens For purposes of this analysis (although corresponds to 1 year at perfect health. drug store chains. In its latest report, the we have no documented basis for estimating those numbers), we assume (These amounts might reasonably be Partnership reported that to date it had that the expected longevity for each halved for average nursing home vaccinated about 2.2 million residents group is identical on average, and that residents, since non-institutionalized in long-term care facilities, although a total of 3.9 million persons are served U.S. adults aged 80–89 years report fewer than two thirds of these had average health-related quality of life 90 each year. We further assume that 20 received two doses. We do know that percent of these are new residents each (HRQL) scores of 0.753, and this figure significant fractions of staff, perhaps is likely to be lower for nursing home year who must be offered vaccination one-third or more, have to date declined residents.) 88 Assuming that the average (most are already vaccinated, as vaccination when offered.91 Progress life expectancy of long-term care discussed later in the analysis). has been very substantial, but many residents is five years, the monetized These nursing facilities have about remain unvaccinated among both benefits of saving one statistical life 950,000 full-time equivalent employees. residents and staff. This interim final would be about $2.5 million ($540,000 For these persons, the average age is rule has significant potential to support × annually for 5 years) at a 3 percent about 50, which creates two offsetting further vaccinations as vaccination discount rate and about $3.7 million effects: They have more years of life opportunities from other sources ($900,000 × annually for 5 years) at a 7 expectancy than residents, but their risk expand. percent discount rate. Assuming that the of from COVID–19 death is far lower. average rate of death from COVID–19 The preceding calculations address For purposes of this analysis, we (SARS-CoV–2 infection) at nursing residential long-term care. Long-term assume that the vaccination is effective home resident ages and conditions is 5 residents are a major group within for at least one year, and use a one-year percent, and the average rate of death nursing homes and are generally in the period as our primary framework for after vaccination is essentially zero, the nursing home because their needs are calculation of potential benefits, not as expected life-extending value of each more substantial and they need a specific prediction but as a likely resident receiving the full course of two assistance with the activities of daily scenario that avoids forecasting major vaccines who would otherwise be living, such as cooking, bathing, and and unexpected changes that are either infected is $125 thousand at a 3 percent dressing. These long-term stays are strongly adverse or strongly beneficial. discount rate and $185 thousand at a 7 primarily funded by the Medicaid If we were adding up totals for benefits percent discount rate. A similar program (also, through long-term care we would assume that the risk of death calculation can be made for staff, who insurance or self-financed), and the after COVID–19 infection is likely only will gain many more years of life but residential care services these residents one-half of one percent (one tenth of the whose risk of death is far smaller since receive are not normally covered by resident rate) or less for the their age distribution is so much Medicare or any other health insurance. unvaccinated members of this group, younger. Yet another calculation for A second major group within the same reflecting the far lower mortality rates clients of ICFs–IID would also result in facilities receives short-term skilled for persons who are mostly in the 30 to nursing care services. These services are 65 year old age ranges compared to the many more years of life but far smaller 93 risks of death since their age rehabilitative and generally last only far older residents. We assume that the distribution is typically far younger than days, weeks, or months. They usually total number of individual employees is that of LTC residents. It is difficult to follow a hospital stay and are primarily 50 percent higher than the full-time ascertain the number of ICF–IID clients funded by the Medicare program or equivalent but that only half that that would be infected without other health insurance. The importance number are primarily employed at only vaccination. Deaths from COVID–19 in of these distinctions is that the numbers one nursing facility, two offsetting unvaccinated LTC residents to date are of residents in each category are assumptions about the number of about 130,000, or close to one tenth of different. The average number of employees working at each facility the average LTC resident census of 1.4 persons in facilities for long-term care (many employees are part-time million, a huge contrast to the handful over the course of a year is about 1.2 consultants or the equivalent who serve of deaths in the vaccination results from million residents (as is the point-in-time multiple nursing facilities on a part-time basis). We further assume that employee Israel.89 We do not have sufficient data number), and the total number of turnover is 80 percent a year, lower than so as to accurately estimate annual persons over the course of a year is the results for nurses previously cited. resident inflows and outflows over time, about 1.6 million. The average number Accordingly, we estimate that 80 but it is clear that several hundred in skilled nursing care over a year is thousand new individuals each year about 200,000 million persons, but the average length of stay is weeks rather 92 In fact, the average length of stay for skilled make the total number served during the nursing care is about 25 days. See MEDPAC, Report to the Congress: Medicare Payment Policy, March 88 Hanmer, J. W.F. Lawrence, J.P. Anderson, R.M. 90 See https://www.cdc.gov/vaccines/covid-19/ 2019, ‘‘Skilled nursing facility services,’’ page 200. Kaplan, D.G. Fryback. 2006. ‘‘Report of Nationally planning/index.html. 93 See the previously cited CDC report on risks by Representative Values for the Noninstitutionalized 91 See the discussion and data in the CDC report age group. In the age intervals used by CDC, the 40– US Adult Population for 7 Health-Related Quality- ‘‘Early COVID–19 First-Dose Vaccination Coverage 49 year old group is in the middle of typical of-Life Scores.’’ Medical Decision Making. 26(4): Among Residents and Staff Members of Skilled employment age ranges. The risk of death in this 391–400. Nursing Facilities Participating in the Pharmacy age group is one tenth that of those aged 65–74. We 89 Deaths are from COVID–19 Nursing Home Data, Partnership for Long-Term Care Program—United emphasize with round numbers that nothing about CMS, Week Ending 2/21/2021, at https:// States, December 2020–January 2021,’’ at https:// these data are fixed and unlikely to change (e.g., as data.cms.gov/stories/s/COVID-19-Nursing-Home- www.cdc.gov/mmwr/volumes/70/wr/mm7005e2. better future treatments are used to treat severe Data/bkwz-xpvg/. htm?s_cid=mm7005e2_x. cases).

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percent of 950,000, or 760,000, are new Hence, the age-weighted hospitalization during the months served by the employees each year and must be rate that we project is about 16 percent. Pharmacy Partnership effort. For offered vaccination (again, most are Among those hospitalized at any age, example, our estimated vaccination rate already vaccinated), for a total of the average cost is about $20,000.96 as of March 31, 2021, for LTC residents 1,710,000 eligible employees over the To put these cost, benefit, and volume assumes that about 90 percent of the course of a year. numbers in perspective, vaccinating one residents in January through March will As for ICFs–IID, there are about 6,000 hundred previously unvaccinated LTC have been vaccinated. But given the facilities, serving about 100,000 people residents who would otherwise become turnover expected during the rest of the at any one time, an average of about 15 infected with SARS–CoV–2 and have a year, only about 70 percent of the people per facility.94 The age profile of COVID–19 illness would cost annual total will have been vaccinated these clients is similar to that of the approximately $54,200 ($542 × 100) in by the end of 2021, or by the end of the adult population at large. Turnover rates paperwork, education, and vaccination first year including the first quarter of are unknown, but likely to be costs. Using the VSL approach to 2022. As a result, about 3.6 million substantial because these clients have estimation would produce life-saving persons will be vaccination candidates many alternatives. We estimate 80 benefits of about $2,650,000 for these subject to this rule over the first year. percent a year for turnover, the same as 100 people ($530,000 × 100 × .05), again Some of these persons may have been for nursing facilities. The costs and assuming the death rate for those ill vaccinated elsewhere, but the facilities benefits of COVID–19 vaccination from COVID–19 of this age and regulated under this rule will need to services for this group are roughly condition is one in twenty. Reductions query each incoming resident and it is comparable to those of nursing home in health care costs from hospitalization likely that as many as a third of these staff. There do not appear to be data on would produce another $320,000 will be candidates for COVID–19 number of staff at these facilities, but ($20,000 × 100 × .16) in benefits for this vaccination. A major caution about based on the nature of the services group assuming that 16% would these estimates: None of the sources of provided it appears likely that the staff otherwise be hospitalized. However, enrollment information for these to client ratio is similar to that in other this comparison is should be taken as programs regularly collect and publish congregate settings (group homes, necessarily hypothetical and contingent information on client or staff turnover assisted living facilities), and likely to due to the analytic, data, and during the course of a year. The be about three-fourths of the client uncertainty challenges discussed estimates here are based on inferences population, or about 75,000 full-time throughout this regulatory impact from scattered data on average length of equivalent staff, with similar turnover assessment. As the discussion of other stay, mortality, job vacancies, news patterns as well. Adding 80 percent to patient groups covered by this rule accounts, and other sources that by allow for staff turnover, gives a total of demonstrates, they present similar if not happenstance are available for one type 135,000 staff candidates for vaccination. identical magnitudes of both costs and of facility or type of resident or another. We have some data on the costs of benefits for affected individuals Nor do we have data on the number of treating serious illness among the (benefits from staff vaccinations, persons in these settings who will be unvaccinated who become infected, are however, are far lower). Consequently, vaccinated through other means during hospitalized, and survive. Among those the primary medium- to long-run the remainder of the year. age 65 years or above, or with severe benefit-cost issue is not the general There are also dimensions of positive risk factors, as many as 40 percent of magnitude of likely effects on those who and negative benefits in the medium- to those known to be infected required get vaccinated as a result of the rule, but long-run that we have not been able to hospitalization in the first month of the the difficult questions of estimating (1) estimate. For example, there is pandemic. Among adults age 21 years to likely numbers of individuals in both insufficient evidence as to whether the 64 years, about 10 percent of those client and staff categories who are likely current or reasonably foreseeable infected required hospitalization.95 For to be unvaccinated when the rule goes vaccines will maintain their protective our estimates, we assume a 20 percent into effect and (2) to be willing to accept efficacy for more than six months. hospitalization rate among people aged vaccination in the coming months and Until very recently, demand for 65 years or older in nursing homes, years.97 COVID–19 vaccination has exceeded reflecting both that their conditions are Of particular importance is that the supply throughout the U.S.98 Especially significantly worse than those of vaccination rates and raw numbers of in previous months, vaccination similarly aged adults living people vaccinated take into account that distribution policies giving priority to independently, and that pre- in total only about half of those who various groups (for example, aged, hospitalization treatments have will be residents and clients in these health care workers, and other essential improved. Of the LTC facility and ICF– facilities at some time during the year services workers) has meant that those IID candidates for vaccination in the have already been residents or clients given priority have benefited to some first year covered by this rule, about extent at the expense of those in lower 96 This is not a robust estimate, but is supported priorities. Regardless of priorities, we three-fourths are age 65 years or above. by several sources. See for example Jiangzhuo Chen et al., ‘‘Medical costs of keeping the US economy know that younger persons are much 94 By far the largest source of data related to ICF open during COVID–19,’’ Scientific Reports, less likely to experience hospitalization and other IID services is ‘‘In-Home and Residential Nature.com, July 19 2020, at https:// or death after infection. For example, Long-Term Supports and Services for Persons with pubmed.ncbi.nlm.nih.gov/32743613/, and Michel the risk of death among infected persons Intellectual or Developmental Disabilities: Status Kohli et al., ‘‘The potential public health and and Trends 2017’’, at https://ici-s.umn.edu/files/ economic value of a hypothetical COVID–19 age 65 to 74 years is ten times greater aCHyYaFjMi/risp_2017. vaccine in the United States: Use of cost- 95 There are few data sources for this statistic and, effectiveness modeling to inform vaccination 98 The shortage issue has now largely been thus, it may be out of date. See MMWR, prioritization,’’ Science Direct, February 12, 2021, addressed, as is well illustrated in the recent ‘‘Preliminary Estimates of the Prevalence of at https://pubmed.ncbi.nlm.nih.gov/33483216/. removal of age restrictions designed to give highest Selected Underlying Health Conditions Among 97 For a survey of the evidence on this issue, see priority in using limited vaccine supplies to the Patients with Coronavirus Disease 2019—United Gillian K. Steelfisher et al., ‘‘An Uncertain Public— elderly and health care workers. See, for example, States, February 12–March 28, 2020’’, April 3, 2020, Encouraging Acceptance of Covid-19 Vaccines,’’ news stories: https://www.abc27.com/news/health/ at https://www.cdc.gov/mmwr/volumes/69/wr/ The New England Journal of Medicine, March 3, coronavirus/official-biden-moving-vaccine- mm6913e2.htm#T2_down. 2021. eligibility-date-to-april-19/.

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than the risk of death among infected the RFA because they are either number of small rural hospitals. This persons age 40 to 49 years. Yet the nonprofit organizations or meet the SBA interim final rule is also exempt because average years of remaining life among definition of a small business (having that provision of law only applies to younger persons at these ages is far revenues of less than $8.0 million to final rules for which a proposed rule greater than among older persons at $41.5 million in any 1 year). HHS uses was published. higher ages. Age, however, is not an increase in costs or decrease in 4. Unfunded Mandates Reform Act anywhere near a perfect indicator of risk revenues of more than 3 to 5 percent as since, for example, health care workers its measure of ‘‘significant economic Section 202 of the Unfunded and those with immune system impact.’’ The HHS standard for Mandates Reform Act of 1995 (UMRA) disorders face elevated risks from ‘‘substantial number’’ is 5 percent or requires that agencies assess anticipated exposure. Sorting out all these factors to more of those that will be significantly costs and benefits before issuing any reach either a qualitative or quantitative impacted, but never fewer than 20. rule whose mandates will impose estimate of net benefits from any The average annual cost of a nursing spending costs on state, local, or tribal particular policy is extremely complex home stay is about $271.98 per day or governments, or by the private sector, and is one reason why vaccination about $100,000 per year.99 As estimated require spending in any 1 year of $100 priorities have differed among the states previously, the average annual cost of million in 1995 dollars, updated and over time. this rule is about $24.70 per resident or annually for inflation. In 2021, that All these data and estimation staff person in the first year. This cost threshold is approximately $158 limitations apply to even the short-term does not approach the 3 percent million. This rule does contain impacts of this rule, and major threshold. For ICFs–IID, one estimate of mandates on private sector entities, and uncertainties remain as to the future average annual costs per client is we estimate the resulting amount to be course of the pandemic, including but $140,000, also a level at which this rule about the same as this threshold in the not limited to vaccine effectiveness in does not approach the 3 percent first year. This IFC was not preceded by preventing disease transmission from threshold.100 Moreover, since most or a notice of proposed rulemaking, and those vaccinated, and the long-term all of these costs will be reimbursed therefore the requirements of UMRA do effectiveness of vaccination. through the CARES Act or other not apply. The information in this RIA COVID–19 funding sources, the and the preamble as a whole would, E. Other Effects financial strain on these facilities however, meet the requirements of 1. Sources of Payment should be negligible and the likely net UMRA. We anticipate that virtually all of the effect positive. Considering the cost 5. Federalism savings from treating seriously ill costs of this rule will be reimbursed Executive Order 13132 establishes residents, the financial impact is likely from funds already appropriated under certain requirements that an agency to be positive. Therefore, the the CARES Act and the American must meet when it promulgates a Department has determined that this Rescue Plan Act of 2021. For example, proposed rule (and subsequent final interim final rule will not have a the amounts provided in the Provider rule) that imposes substantial direct significant economic impact on a Relief Fund is $7.4 billion, many times requirement costs on state and local substantial number of small entities and more than the relatively small costs of governments, preempts state law, or that a final RIA is not required. Finally, this rule. As previously discussed, if otherwise has federalism implications. this IFC was not preceded by a general there are treatment cost savings to Nothing in this rule will have a notice of proposed rulemaking and the hospitals and other care providers as a substantial direct effect on state or local RFA requirement for a final regulatory result of the vaccinations that will be governments, preempt state laws, or flexibility analysis does not apply to made due to this rule, the treatment cost otherwise have federalism implications. savings would in turn result in savings final rules not preceded by a proposed F. Alternatives Considered to payers. It is likely that half or more rule. of these savings would primarily accrue 3. Small Rural Hospitals As discussed earlier in the preamble, a major substantive alternative that we to Medicare given the elderly or Section 1102(b) of the Social Security disability status of most clients and considered was to require vaccination Act requires us to prepare a RIA if a activities (education and offering) for all Medicare’s role as primary payer, but proposed rule may have a significant there would also be substantial savings persons who may provide paid or impact on the operations of a substantial unpaid services, such as visiting to Medicaid, private insurance paid by number of small rural hospitals. For employers and employees, and private specialists or volunteers, who are not on purposes of this requirement, we define the regular payroll on a weekly or more out-of-pocket payers including a small rural hospital as a hospital that residents. frequent basis. That is, individuals who is located outside of a metropolitan work in the facility infrequently. We 2. Regulatory Flexibility Act statistical area and has fewer than 100 also considered including visitors, such The RFA requires agencies to analyze beds. Because this rule has no direct as family members. All these categories options for regulatory relief of small effects on any hospitals, the Department present major problems for compliance, entities, if a rule has a significant impact has determined that this interim final enforcement, and record-keeping, as on a substantial number of small rule will not have a significant impact well as a multitude of complexities entities. Under the RFA, ‘‘small on the operations of a substantial related to visit frequency, resident entities’’ include small businesses, exposure, and vaccination management. 99 See Marcum Accountants & Advisors, A Five nonprofit organizations, and small Year Nursing Home Statistical Analysis (2014 to Furthermore, the efficacy of such a governmental jurisdictions. Individuals 2018), at https://www.marcumllp.com/wp-content/ policy would be difficult to establish. and states are not included in the uploads/marcum-five-year-nursing-home- For example, vaccinating a one-time definition of a small entity. For statistical-analysis-2014-2018.pdf. visitor on the day of their visit would 100 See In-Home and Residential Long-Term purposes of the RFA, we estimate that Supports and Services for Persons with Intellectual not improve resident safety because the many LTC facilities and most ICFs–IID or Developmental Disabilities: Status and Trends vaccine is not instantly effective upon are small entities as that term is used in 2017, op cit, page 77. administration. There are also ethical

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issues related to potential treatments and vaccinations and their those vaccinated are all currently discouragement of visiting volunteers or effects in future years and we have no unknown. These uncertainties also family members. Instead, we believe way of knowing which will most likely impinge on benefits estimates. For those that such decisions are best left to each occur. A longer period would be even reasons we have not quantified into facility, in consideration of CMS and more speculative than the current annual totals either the life-extending or CDC guidance. Our expectation is that estimates. medical cost-reducing benefits of this vaccination of regular visitors in any of As explained in various places within rule, and have used only a one-year these categories will be encouraged, the RIA and the preamble as a whole, projection for the cost estimates in our there are major uncertainties as to the whether or not the vaccinations are Accounting Statement (our estimates are effects of COVID–19 on nursing and offered by the facility itself. for the last nine months of 2021 and the other congregate living facilities as well G. Accounting Statement and Table as the nation at large. For example, the first three months of 2022). We welcome The Accounting Table summarizes duration of vaccine effectiveness in comments on all of our assumptions and the quantified impact of this rule. It preventing infection, reducing disease welcome any additional information covers only one year because there will severity, reducing the risk of death, and that would narrow the ranges of likely be many developments regarding preventing disease transmission by uncertainty.

TABLE 7—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS AND SAVINGS [$ Millions]

Units Category Primary Lower bound Upper bound Discount estimate Year dollars rate Period (%) covered

Benefits: Lives Extended (not annualized ...... 2020 7 First year. or monetized). Reduced Medical Expenditures (not ...... 2020 3 First year. annualized or monetized).

Costs: Annualized Monetized ($ million/ 159 119 199 2020 7 First year. year). 159 119 199 2020 3 First year.

Cost Notes: Administrative costs from increased efforts to vaccinate residents and staff.

Transfers ...... None.

In accordance with the provisions of ■ a. Revising the heading for paragraph (iii) Before offering COVID–19 Executive Order 12866, this regulation (d); vaccine, each resident or the resident was reviewed by the Office of ■ b. Adding paragraph (d)(3); representative receives education Management and Budget. ■ c. Removing the word ‘‘and’’ at the regarding the benefits and risks and I, Elizabeth Richter, Acting end of paragraph (g)(1)(vii); potential side effects associated with the Administrator of the Centers for ■ d. Revising paragraph (g)(1)(viii); and COVID–19 vaccine; (iv) In situations where COVID–19 Medicare & Medicaid Services, ■ e. Adding paragraph (g)(1)(ix). vaccination requires multiple doses, the approved this document on April 22, The revisions and additions read as 2021. resident, resident representative, or staff follows: member is provided with current List of Subjects in 42 CFR Part 483 § 483.80 Infection control. information regarding those additional Grant programs-health, Health * * * * * doses, including any changes in the facilities, Health professions, Health (d) Influenza, pneumococcal, and benefits or risks and potential side records, Medicaid, Medicare, Nursing COVID–19 immunizations— *** effects associated with the COVID–19 vaccine, before requesting consent for homes, Nutrition, Reporting and (3) COVID–19 immunizations. The recordkeeping requirements, Safety. administration of any additional doses; LTC facility must develop and (v) The resident, resident For the reasons set forth in the implement policies and procedures to representative, or staff member has the preamble, the Centers for Medicare & ensure all the following: opportunity to accept or refuse a Medicaid Services amends 42 CFR part (i) When COVID–19 vaccine is COVID–19 vaccine, and change their 483 as set forth below: available to the facility, each resident decision; and staff member is offered the COVID– PART 483—REQUIREMENTS FOR (vi) The resident’s medical record 19 vaccine unless the immunization is STATES AND LONG TERM CARE includes documentation that indicates, medically contraindicated or the FACILITIES at a minimum, the following: resident or staff member has already (A) That the resident or resident ■ 1. The authority citation for part 483 been immunized; representative was provided education continues to read as follows: (ii) Before offering COVID–19 vaccine, regarding the benefits and potential all staff members are provided with risks associated with COVID–19 Authority: 42 U.S.C. 1302, 1320a–7, 1395i, education regarding the benefits and vaccine; and 1395hh and 1396r. risks and potential side effects (B) Each dose of COVID–19 vaccine ■ 2. Section 483.80 is amended by— associated with the vaccine; administered to the resident; or

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(C) If the resident did not receive the (f) Standard: COVID–19 vaccines. The regarding the benefits and risks and COVID–19 vaccine due to medical facility maintains documentation potential side effects associated with the contraindications or refusal; and related to staff that includes at a COVID–19 vaccine. (vii) The facility maintains minimum, all of the following: (iv) In situations where COVID–19 documentation related to staff COVID– (1) Staff were provided education vaccination requires multiple doses, the 19 vaccination that includes at a regarding the benefits and risks and client, client’s representative, or staff minimum, the following: potential side effects associated with the member is provided with current (A) That staff were provided COVID–19 vaccine. information regarding each additional education regarding the benefits and (2) Staff were offered COVID–19 dose, including any changes in the potential risks associated with COVID– vaccine or information on obtaining the benefits or risks and potential side 19 vaccine; COVID–19 vaccine. effects associated with the COVID–19 (B) Staff were offered the COVID–19 ■ 4. Section 483.460 is amended by vaccine, before requesting consent for vaccine or information on obtaining redesignating paragraph (a)(4) as administration of each additional doses. COVID–19 vaccine; and paragraph (a)(5) and adding new (v) The client, client’s representative, (C) The COVID–19 vaccine status of paragraph (a)(4) to read as follows: or staff member has the opportunity to staff and related information as § 483.460 Conditions of participation: accept or refuse COVID–19 vaccine, and indicated by the Centers for Disease Health care services. change their decision. Control and Prevention’s National (a) * * * (vi) The client’s medical record Healthcare Safety Network (NHSN). (4) The intermediate care facility for includes documentation that indicates, * * * * * individuals with intellectual disabilities at a minimum, the following: (g) * * * (ICF/IID) must develop and implement (A) That the client or client’s (1) * * * policies and procedures to ensure all of representative was provided education (viii) The COVID–19 vaccine status of the following: regarding the benefits and risks and residents and staff, including total (i) When COVID–19 vaccine is potential side effects of COVID–19 numbers of residents and staff, numbers available to the facility, each client and vaccine; and of residents and staff vaccinated, staff member is offered the COVID–19 (B) Each dose of COVID–19 vaccine numbers of each dose of COVID–19 vaccine unless the immunization is administered to the client; or vaccine received, and COVID–19 medically contraindicated or the client (C) If the client did not receive the vaccination adverse events; and or staff member has already been COVID–19 vaccine due to medical (ix) Therapeutics administered to immunized. contraindications or refusal. residents for treatment of COVID–19. (ii) Before offering COVID–19 vaccine, * * * * * all staff members are provided with * * * * * Dated: May 10, 2021. ■ 3. Section 483.430 is amended by education regarding the benefits and Xavier Becerra, adding paragraph (f) to read as follows: risks and potential side effects associated with the vaccine. Secretary, Department of Health and Human § 483.430 Condition of participation: (iii) Before offering COVID–19 Services. Facility staffing. vaccine, each client or the client’s [FR Doc. 2021–10122 Filed 5–11–21; 11:15 am] * * * * * representative receives education BILLING CODE 4120–01–P

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