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        <title>Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff</title>
        <partNumber>Part III</partNumber>
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    <abstract>This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as "nursing homes") and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.</abstract>
    <identifier type="FR citation">86 FR 26306</identifier>
    <identifier type="uri">https://www.govinfo.gov/app/details/FR-2021-05-13/2021-10122</identifier>
    <identifier type="FR Doc No.">2021-10122</identifier>
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        <topic>Grant Programs-Health</topic>
        <topic>Health Facilities</topic>
        <topic>Health Professions</topic>
        <topic>Health Records</topic>
        <topic>Medicaid</topic>
        <topic>Medicare</topic>
        <topic>Nursing Homes</topic>
        <topic>Nutrition</topic>
        <topic>Reporting and Recordkeeping Requirements</topic>
        <topic>Safety</topic>
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        <extent>31 p.</extent>
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            <start>26306</start>
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    <identifier type="preferred citation">86 FR 26306</identifier>
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            <partNumber>Title 42 Part 483</partNumber>
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        <searchTitle>Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff; Federal Register Vol. 86, Issue </searchTitle>
        <granuleClass>RULE</granuleClass>
        <accessId>2021-10122</accessId>
        <partNumber>III</partNumber>
        <agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
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        <action>Interim final rule with comment period.</action>
        <summary>This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as "nursing homes") and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.</summary>
        <dates>These regulations are effective on May 21, 2021.</dates>
        <contact>Diane Corning, (410) 786-8486, Lauren Oviatt, (410) 786-4683, Kim Roche, (410) 786-3524, or Kristin Shifflett, (410) 786-4133, for all rule related issues.</contact>
        <cfr title="42">
                                    
            <part number="483"/>
                                    
            <subject>Grant Programs-Health</subject>
                                    
            <subject>Health Facilities</subject>
                                    
            <subject>Health Professions</subject>
                                    
            <subject>Health Records</subject>
                                    
            <subject>Medicaid</subject>
                                    
            <subject>Medicare</subject>
                                    
            <subject>Nursing Homes</subject>
                                    
            <subject>Nutrition</subject>
                                    
            <subject>Reporting and Recordkeeping Requirements</subject>
                                    
            <subject>Safety</subject>
                                
        </cfr>
        <tocSubject1>Medicare and Medicaid Programs:
</tocSubject1>
        <tocDoc>COVID19 Vaccine Requirements for Long-Term Care Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities Residents, Clients, and Staff, </tocDoc>
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        <urlRef>http://www.regulations.gov</urlRef>
        <urlRef>https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis</urlRef>
        <urlRef>https://aspe.hhs.gov/system/files/pdf/76956/MFIS.pdf</urlRef>
        <urlRef>https://covid.cdc.gov/covid-data-tracker/#datatracker-home</urlRef>
        <urlRef>https://covid.cdc.gov/covid-data-tracker/#vaccinations-ltc</urlRef>
        <urlRef>https://covidtracking.com/nursing-homes-long-term-care-facilities</urlRef>
        <urlRef>https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/</urlRef>
        <urlRef>https://fred.stlouisfed.org/series/MEPAINUSA672N</urlRef>
        <urlRef>https://ici-s.umn.edu/files/aCHyYaFjMi/risp_2017</urlRef>
        <urlRef>https://pediatrics.aappublications.org/content/145/3/e20193995</urlRef>
        <urlRef>https://pubmed.ncbi.nlm.nih.gov/32743613/</urlRef>
        <urlRef>https://pubmed.ncbi.nlm.nih.gov/33483216/</urlRef>
        <urlRef>https://s3.amazonaws.com/media2.fairhealth.org/whitepaper/asset/Risk%20Factors%20for%20COVID-19%20Mortality%20among%20Privately%20Insured%20Patients%20-%20A%20Claims%20Data%20Analysis%20-%20A%20FAIR%20Health%20White%20Paper.pdf</urlRef>
        <urlRef>https://tcf.org/content/commentary/even-nursing-homes-covid-19-racial-disparities-persist/?agreed=1</urlRef>
        <urlRef>https://vaers.hhs.gov/</urlRef>
        <urlRef>https://www.abc27.com/news/health/coronavirus/official-biden-moving-vaccine-eligibility-date-to-april-19/</urlRef>
        <urlRef>https://www.ada.gov/olmstead/S</urlRef>
        <urlRef>https://www.bls.gov/oes/current/oes119111.htm</urlRef>
        <urlRef>https://www.bls.gov/oes/current/oes291141.htm</urlRef>
        <urlRef>https://www.bls.gov/oes/current/oes291228.htm#</urlRef>
        <urlRef>https://www.bls.gov/oes/current/oes433099.htm</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/people-with-disabilities.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/community/group-homes.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-residents.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-developmental-disabilities.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/disabilities.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/resource-center.html</urlRef>
        <urlRef>https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html</urlRef>
        <urlRef>https://www.cdc.gov/longtermcare/</urlRef>
        <urlRef>https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm#T2_down</urlRef>
        <urlRef>https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm</urlRef>
        <urlRef>https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm</urlRef>
        <urlRef>https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm?s_cid=mm7005e2_x</urlRef>
        <urlRef>https://www.cdc.gov/nchs/nvss/vsrr/COVID19/index.htm</urlRef>
        <urlRef>https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html</urlRef>
        <urlRef>https://www.cdc.gov/nhsn/pdfs/covid19/ltcf/57.158-toi-508.pdf</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships.html</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/phased-implementation.html#congregate-living-settings</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/planning/index.html</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html</urlRef>
        <urlRef>https://www.cdc.gov/vaccines/pandemic-guidance/index.html</urlRef>
        <urlRef>https://www.cms.gov/newsroom/press-releases/cms-releases-nursing-home-covid-19-training-data-urgent-call-action</urlRef>
        <urlRef>https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines</urlRef>
        <urlRef>https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19</urlRef>
        <urlRef>https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</urlRef>
        <urlRef>https://www.fda.gov/media/144413/download</urlRef>
        <urlRef>https://www.fda.gov/media/144637/download</urlRef>
        <urlRef>https://www.fda.gov/media/146304/download</urlRef>
        <urlRef>https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance</urlRef>
        <urlRef>https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR27550#</urlRef>
        <urlRef>https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR54820#</urlRef>
        <urlRef>https://www.foia.gov/faq.html</urlRef>
        <urlRef>https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094</urlRef>
        <urlRef>https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00957</urlRef>
        <urlRef>https://www.healthline.com/health-news/how-much-will-it-cost-to-get-a-covid-19-vaccine</urlRef>
        <urlRef>https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html</urlRef>
        <urlRef>https://www.kff.org/070b9a9/</urlRef>
        <urlRef>https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor/</urlRef>
        <urlRef>https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce/</urlRef>
        <urlRef>https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/</urlRef>
        <urlRef>https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/#longtermcare</urlRef>
        <urlRef>https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/</urlRef>
        <urlRef>https://www.marcumllp.com/wp-content/uploads/marcum-five-year-nursing-home-statistical-analysis-2014-2018.pdf</urlRef>
        <urlRef>https://www.medicaid.gov/medicaid/long-term-services-supports/workforce-initiative/index.html</urlRef>
        <urlRef>https://www.medicaid.gov/sites/default/files/2019-12/mfp-rtc.pdf</urlRef>
        <urlRef>https://www.medicare.gov/care-compare/</urlRef>
        <urlRef>https://www.medrxiv.org/content/10.1101/2021.02.05.21251139v3.full.pdf</urlRef>
        <urlRef>https://www.modernatx.com/covid19vaccine-eua/providers/language-resources</urlRef>
        <urlRef>https://www.nejm.org/doi/full/10.1056/NEJMoa2101765</urlRef>
        <urlRef>https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx</urlRef>
        <urlRef>https://www.ssa.gov/OP_Home/ssact/title18/1819.htm</urlRef>
        <urlRef>https://www.ssa.gov/OP_Home/ssact/title19/1919.htm</urlRef>
        <urlRef>https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/</urlRef>
        <urlRef>https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094</urlRef>
        <urlRef>Nature.com</urlRef>
        <urlRef>Regulations.gov</urlRef>
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