Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

CourtCenters For Medicare & Medicaid Services
Citation86 FR 61555
Published date05 November 2021
Record Number2021-23831
Federal Register, Volume 86 Issue 212 (Friday, November 5, 2021)
[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
                [Rules and Regulations]
                [Pages 61555-61627]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-23831]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 416, 418, 441, 460, 482, 483, 484, 485, 486, 491 and
                494
                [CMS-3415-IFC]
                RIN 0938-AU75
                Medicare and Medicaid Programs; Omnibus COVID-19 Health Care
                Staff Vaccination
                AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
                ACTION: Interim final rule with comment period.
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                SUMMARY: This interim final rule with comment period revises the
                requirements that most Medicare- and Medicaid-certified providers and
                suppliers must meet to participate in the Medicare and Medicaid
                programs. These changes are necessary to help protect the health and
                safety of residents, clients, patients, PACE participants, and staff,
                and reflect lessons learned to date as a result of the COVID-19 public
                health emergency. The revisions to the requirements establish COVID-19
                vaccination requirements for staff at the included Medicare- and
                Medicaid-certified providers and suppliers.
                DATES:
                 Effective date: These regulations are effective on November 5,
                2021.
                 Implementation dates: The regulations included in Phase 1 [42 CFR
                416.51(c) through (c)(3)(i) and (c)(3)(iii) through (x), 418.60(d)
                through (d)(3)(i) and (d)(3)(iii) through (x), 441.151(c) through
                (c)(3)(i) and (c)(3)(iii) through (x), 460.74(d) through (d)(3)(i) and
                (d)(3)(iii) through (x), 482.42(g) through (g)(3)(i) and (g)(3)(iii)
                through (x), 483.80(d)(3)(v) and 483.80(i) through (i)(3)(i) and
                (i)(3)(iii) through (x), 483.430(f) through (f)(3)(i) and (f)(3)(iii)
                through (x), 483.460(a)(4)(v), 484.70(d) through (d)(3)(i) and
                (d)(3)(iii) through (x), 485.58(d)(4), 485.70(n) through (n)(3)(i) and
                (n)(3)(iii) through (x), 485.640(f) through (f)(3)(i) and (f)(3)(iii)
                through (x), 485.725(f) through (f)(3)(i) through (f)(3)(iii) through
                (x), 485.904(c) through (c)(3)(i) and (c)(3)(iii) through (x),
                486.525(c) through (c)(3)(i) and (c)(3)(iii) through (x), 491.8(d)
                through (d)(3)(i) and (d)(3)(iii) through (x), 494.30(b) through
                (b)((3)(i) and (b)(3)(iii) through (x) must be implemented by December
                6, 2021.
                 The regulations included in Phase 2 [42 CFR 416.51(c)(3)(ii),
                418.60(d)(3)(ii), 441.151(c)(3)(ii), 460.74(d)(3)(ii),
                482.42(g)(3)(ii), 483.80(i)(3)(ii), 483.430(f)(3)(ii),
                484.70(d)(3)(ii), 485.70(n)(3)(ii), 485.640(f)(3)(ii),
                485.725(f)(3)(ii), 485.904(c)(3)(ii), 486.525(c)(3)(ii),
                491.8(d)(3)(ii), 494.30(b)(3)(ii)] must be implemented by January 4,
                2022. Staff who have completed a primary vaccination series by this
                date are considered to have met these requirements, even if they have
                not yet completed the 14-day waiting period required for full
                vaccination.
                 Comment date: To be assured consideration, comments must be
                received at one of the addresses provided below, no later than 5 p.m.
                on January 4, 2022.
                ADDRESSES: In commenting, please refer to file code CMS-3415-IFC.
                 Comments, including mass comment submissions, must be submitted in
                one of the following three ways (please choose only one of the ways
                listed):
                 1. Electronically. You may submit electronic comments on this
                regulation to http://www.regulations.gov. Follow the ``Submit a
                comment'' instructions.
                 2. By regular mail. You may mail written comments to the following
                address ONLY: Centers for Medicare & Medicaid Services, Department of
                Health and Human Services, Attention: CMS-3415-IFC, P.O. Box 8016,
                Baltimore, MD 21244-8016.
                 Please allow sufficient time for mailed comments to be received
                before the close of the comment period.
                [[Page 61556]]
                 3. By express or overnight mail. You may send written comments to
                the following address ONLY: Centers for Medicare & Medicaid Services,
                Department of Health and Human Services, Attention: CMS-3415-IFC, Mail
                Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                 For information on viewing public comments, see the beginning of
                the SUPPLEMENTARY INFORMATION section.
                FOR FURTHER INFORMATION CONTACT:
                 For press inquiries: CMS Office of Communications, Department of
                Health and Human Services; email [email protected].
                 For technical inquiries: Contact CMS Center for Clinical Standards
                and Quality, Department of Health and Human Services, (410) 786-6633.
                SUPPLEMENTARY INFORMATION:
                 Inspection of Public Comments: All comments received before the
                close of the comment period are available for viewing by the public,
                including any personally identifiable or confidential business
                information that is included in a comment. We post all comments
                received before the close of the comment period on the following
                website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
                view public comments. CMS will not post on Regulations.gov public
                comments that make threats to individuals or institutions or suggest
                that the individual will take actions to harm the individual. CMS
                continues to encourage individuals not to submit duplicative comments.
                We will post acceptable comments from multiple unique commenters even
                if the content is identical or nearly identical to other comments.
                I. Background
                 The Centers for Medicare & Medicaid Services (CMS) establishes
                health and safety standards, known as the Conditions of Participation,
                Conditions for Coverage, or Requirements for Participation for 21 types
                of providers and suppliers, ranging from hospitals to hospices and
                rural health clinics to long term care facilities (including skilled
                nursing facilities and nursing facilities, collectively known as
                nursing homes). Most of these providers and suppliers are regulated by
                this interim final rule with comment period (IFC). Specifically, this
                IFC directly regulates the following providers and suppliers, listed in
                the numerical order of the relevant CFR sections being revised in this
                rule:
                 Ambulatory Surgical Centers (ASCs) (Sec. 416.51)
                 Hospices (Sec. 418.60)
                 Psychiatric residential treatment facilities (PRTFs) (Sec.
                441.151)
                 Programs of All-Inclusive Care for the Elderly (PACE) (Sec.
                460.74)
                 Hospitals (acute care hospitals, psychiatric hospitals,
                hospital swing beds, long term care hospitals, children's hospitals,
                transplant centers, cancer hospitals, and rehabilitation hospitals/
                inpatient rehabilitation facilities) (Sec. 482.42)
                 Long Term Care (LTC) Facilities, including Skilled Nursing
                Facilities (SNFs) and Nursing Facilities (NFs), generally referred to
                as nursing homes (Sec. 483.80)
                 Intermediate Care Facilities for Individuals with Intellectual
                Disabilities (ICFs-IID) (Sec. 483.430)
                 Home Health Agencies (HHAs) (Sec. 484.70)
                 Comprehensive Outpatient Rehabilitation Facilities (CORFs)
                (Sec. Sec. 485.58 and 485.70)
                 Critical Access Hospitals (CAHs) (Sec. 485.640)
                 Clinics, rehabilitation agencies, and public health agencies
                as providers of outpatient physical therapy and speech-language
                pathology services (Sec. 485.725)
                 Community Mental Health Centers (CMHCs) (Sec. 485.904)
                 Home Infusion Therapy (HIT) suppliers (Sec. 486.525)
                 Rural Health Clinics (RHCs)/Federally Qualified Health Centers
                (FQHCs) (Sec. 491.8)
                 End-Stage Renal Disease (ESRD) Facilities (Sec. 494.30)
                 This IFC directly applies only to the Medicare- and Medicaid-
                certified providers and suppliers listed above. It does not directly
                apply to other health care entities, such as physician offices, that
                are not regulated by CMS. Most states have separate licensing
                requirements for health care staff and health care providers that would
                be applicable to physician office staff and other staff in small health
                care entities that are not subject to vaccination requirements under
                this IFC. We have not included requirements for Organ Procurement
                Organizations or Portable X-Ray suppliers, as these only provide
                services under contract to other health care entities and would thus be
                indirectly subject to the vaccination requirements of this rule, as
                discussed in section II.A.1. of this rule. We note that entities not
                covered by this rule may still be subject to other State or Federal
                COVID-19 vaccination requirements, such as those issued by Occupational
                Safety and Health Administration (OSHA) for certain employers.
                 Currently, the United States (U.S.) is responding to a public
                health emergency (PHE) of respiratory disease caused by a novel
                coronavirus that has now been detected in more than 190 countries
                internationally, all 50 States, the District of Columbia, and all U.S.
                territories. The virus has been named ``severe acute respiratory
                syndrome coronavirus 2'' (SARS-CoV-2), and the disease it causes has
                been named ``coronavirus disease 2019'' (COVID-19). On January 30,
                2020, the International Health Regulations Emergency Committee of the
                World Health Organization (WHO) declared the outbreak a ``Public Health
                Emergency of International Concern.'' On January 31, 2020, pursuant to
                section 319 of the Public Health Service Act (PHSA) (42 U.S.C. 247d),
                the Secretary of the Department of Health and Human Services
                (Secretary) determined that a PHE exists for the U.S. (hereafter
                referred to as the PHE for COVID-19). On March 11, 2020, the WHO
                publicly declared COVID-19 a pandemic. On March 13, 2020, the President
                of the United States declared the COVID-19 pandemic a national
                emergency. The January 31, 2020 determination that a PHE for COVID-19
                exists and has existed since January 27, 2020, lasted for 90 days, and
                was renewed on April 21, 2020; July 23, 2020; October 2, 2020; January
                7, 2021; April 15, 2021; July 19, 2021; and October 18, 2021. Pursuant
                to section 319 of the PHSA, the determination that a PHE continues to
                exist may be renewed at the end of each 90-day period.\1\
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                 \1\ https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx.
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                 COVID-19 has had significant negative health effects--on
                individuals, communities, and the nation as a whole. Consequences for
                individuals who have COVID-19 include morbidity, hospitalization,
                mortality, and post-COVID conditions (also known as long COVID). As of
                mid-October 2021, over 44 million COVID-19 cases, 3 million new COVID-
                19 related hospitalizations, and 720,000 COVID-19 deaths have been
                reported in the U.S.\2\ Indeed, COVID-19 has overtaken the 1918
                influenza pandemic as the deadliest disease in American history.\3\
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                 \2\ https://covid.cdc.gov/covid-data-tracker#datatracker-home.
                 \3\ https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history.
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                [[Page 61557]]
                 Given recent estimates of undiagnosed infections and under-reported
                deaths, these figures likely underestimate the full impact.\4\ In
                addition, these figures fail to capture the significant, detrimental
                effects of post-acute illness, including nervous system and
                neurocognitive disorders, cardiovascular disorders, gastrointestinal
                disorders, and signs and symptoms related to poor general well-being,
                including malaise, fatigue, musculoskeletal pain, and reduced quality
                of life. Recent estimates suggest more than half of COVID-19 survivors
                experienced post-acute sequelae of COVID-19 6 months after recovery.\5\
                The individual and public health ramifications of COVID-19 also extend
                beyond the direct effects of COVID-19 infections. Several studies have
                demonstrated significant mortality increases in 2020, beyond those
                attributable to COVID-19 deaths. In some percentage, this could be a
                problem of misattribution (for example, the cause of death was
                indicated as ``heart disease'' but in fact the true cause was
                undiagnosed COVID-19), but some proportion are also believed to reflect
                increases in other causes of death that are sensitive to decreased
                access to care and/or increased mental/emotional strain. One paper
                quantifies the net impact (direct and indirect effects) of the pandemic
                on the U.S. population during 2020 using three metrics: excess deaths,
                life expectancy, and total years of life lost. The findings indicate
                there were 375,235 excess deaths, with 83 percent attributable to
                direct, and 17 percent attributable to indirect effects of COVID-19.
                The decrease in life expectancy was 1.67 years, translating to a
                reversion of 14 years in historical life expectancy gains. Total years
                of life lost in 2020 was 7,362,555 across the U.S. (73 percent directly
                attributable, 27 percent indirectly attributable to COVID-19), with
                considerable heterogeneity at the individual State level.\6\
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                 \4\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354557/.
                 \5\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918.
                 \6\ https://pubmed.ncbi.nlm.nih.gov/34469474/.
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                 One analysis published in February 2021 found that Black and Latino
                Americans have experienced a disproportionate burden of COVID-19
                morbidity and mortality, reflecting persistent structural inequalities
                that increase risk of exposure to COVID-19 and mortality risk for those
                infected. The authors projected that COVID-19 would reduce U.S. life
                expectancy in 2020 by 1.13 years. Furthermore, the estimated reduction
                for Black and Latino populations is 3-4 times the estimate for the
                White population, reversing over 10 years of progress in reducing the
                gaps in life expectancy between Black and White populations and
                reducing the Latino mortality advantage by over 70 percent. The study
                further expects that reductions in life expectancy may persist because
                of continued COVID-19 mortality and term health, social, and economic
                impacts of the pandemic.\7\ Because SARS-CoV-2, the virus that causes
                COVID-19 disease, is highly transmissible,\8\ Centers for Disease
                Control and Prevention (CDC) has recommended, and CMS reiterated, that
                health care providers and suppliers implement robust infection
                prevention and control practices, including source control measures,
                physical distancing, universal use of personal protective equipment
                (PPE), SARS-CoV-2 testing, environmental controls, and patient
                isolation or quarantine.9 10 11 12 Available evidence
                suggests these infection prevention and control practices have been
                highly effective when implemented correctly and consistently.\13\ \14\
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                 \7\ Andrasfay, T., & Goldman, N. (2021). Reductions in 2020 US
                life expectancy due to COVID-19 and the disproportionate impact on
                the Black and Latino populations. Proceedings of the National
                Academy of Sciences of the United States of America, 118(5),
                e2014746118. https://doi.org/10.1073/pnas.2014746118 Accessed 10/17/
                2021.
                 \8\ https://www.npr.org/sections/goatsandsoda/2021/08/11/1026190062/covid-delta-variant-transmission-cdc-chickenpox.
                 \9\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html.
                 \10\ https://www.cms.gov/files/document/qso-21-08-nltc.pdf.
                 \11\ https://www.cms.gov/files/document/qso-21-07-psych-hospital-prtf-icf-iid.pdf.
                 \12\ https://www.cms.gov/files/document/qso-20-38-nh-revised.pdf.
                 \13\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2770287.
                 \14\ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777317.
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                 Studies have also shown, however, that consistent adherence to
                recommended infection prevention and control practices can prove
                challenging--and those lapses can place patients in
                jeopardy.15 16 17 18 A retrospective analysis from England
                found up to 1 in 6 SARS-CoV-2 infections among hospitalized patients
                with COVID-19 in England during the first 6 months of the pandemic
                could be attributed to healthcare-associated transmission.\19\ In
                outbreaks reported from acute care settings in the U.S. following
                implementation of universal masking, unmasked exposures to other health
                care workers were frequently implicated.\20\ A retrospective cohort
                study of health care staff behaviors, exposures, and cases between June
                and December 2020 in a large health system found more employees were
                exposed via coworkers than patients--and secondary cases among
                employees typically followed unmasked interactions with infected
                colleagues (for example, convening in breakrooms without proper source
                control).\21\ The same study found that cases of health care worker
                infection associated with patient exposures could often be attributed
                to failure to adhere to PPE requirements (for example, eye protection).
                Past experience with influenza, and available evidence, suggest that
                vaccination of health care staff offers a critical layer of protection
                against healthcare-associated COVID-19 (HA-COVID-19). For example,
                evidence has shown that influenza vaccination of health care staff is
                associated with declines in nosocomial influenza in hospitalized
                patients,22 23 24 and among nursing home
                residents.25 26 27 28 29 30 31
                [[Page 61558]]
                As a result, CDC, the Society for Healthcare Epidemiology of America,
                and others recommend--and a number of states require-- annual influenza
                vaccination for health care staff.32 33 34
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                 \15\ https://www.pnas.org/content/pnas/118/1/e2015455118.full.pdf.
                 \16\ https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2782430.
                 \17\ https://www.medrxiv.org/content/10.1101/2021.09.08.21263057v1.
                 \18\ https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003816.
                 \19\ https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1.
                 \20\ https://jamanetwork.com/journals/jama/fullarticle/2773128.
                 \21\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/.
                 \22\ Weinstock DM, Eagan J, Malak SA, et al. Control of
                influenza A on a bone marrow transplant unit. Infect Control Hosp
                Epidemiol. 2000; 21:730-732.
                 \23\ Salgado CD, Giannetta ET, Hayden FG, Farr BM. Preventing
                nosocomial influenza by improving the vaccine acceptance rate of
                clinicians. Infect Control Hosp Epidemiol 2004; 25:923-928.
                 \24\ https://pubmed.ncbi.nlm.nih.gov/31384750/.
                 \25\ Hayward AC, Harling R, Wetten S, et al. Effectiveness of an
                influenza vaccine programme for care home staff to prevent death,
                morbidity, and health service use among residents: cluster
                randomised controlled trial. BMJ 2006; 333: 1241-1246.
                 \26\ Potter J, Stott DJ, Roberts MA, et al. Influenza
                vaccination of healthcare workers in long-term-care hospitals
                reduces the mortality of elderly patients. J Infect Dis. 1997;
                175:1-6.
                 \27\ Thomas RE, Jefferson TO, Demicheli V, et al. Influenza
                vaccination for health-care workers who work with elderly people in
                institutions: a systematic review. Lancet Infect Dis. 2006; 6:273-
                279.
                 \28\ Van den Dool C, Bonten MJM, Hak E, Heijne JCM, Wallinga J.
                The effects of influenza vaccination of health care workers in
                nursing homes: insights from a mathematical model. PLoS Medicine.
                2008; 5:1453-1460.
                 Lemaitre M, Meret T, Rothan-Tondeur M, et al. Effect of
                influenza vaccination of nursing home staff on mortality of
                residents: a cluster-randomized trial. J Am Geriatr Soc. 2009;
                57:1580-1586.
                 \29\ Lemaitre M, Meret T, Rothan-Tondeur M, et al. Effect of
                influenza vaccination of nursing home staff on mortality of
                residents: a cluster-randomized trial. J Am Geriatr Soc. 2009;
                57:1580-1586.
                 Van den Dool C, Bonten MJM, Hak E, Heijne JCM, Wallinga J. The
                effects of influenza vaccination of health care workers in nursing
                homes: insights from a mathematical model. PLoS Medicine. 2008;
                5:1453-1460.
                 \30\ Oshitani H, Saito R, Seiki N, et al. Influenza vaccination
                levels and influenza-like illness in long-term-care facilities for
                elderly people in Niigata, Japan, during an influenza A (H3N2)
                epidemic. Infect Control Hosp Epidemiol. 2000; 21:728-730.
                 \31\ https://pubmed.ncbi.nlm.nih.gov/31384750/.
                 \32\ https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm.
                 \33\ https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/revised-shea-position-paper-influenza-vaccination-of-healthcare-personnel/E83D4D87FBBBD80C66A2A4926D00F4B8.
                 \34\ https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html.
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                 In addition to preventing morbidity and mortality associated with
                COVID-19, currently approved or authorized vaccines also demonstrate
                effectiveness against asymptomatic SARS-CoV-2 infection. A recent study
                of health care workers in 8 states found that, between December 14,
                2020 through August 14, 2021, full vaccination with COVID-19 vaccines
                was 80 percent effective in preventing RT-PCR-confirmed SARS-CoV-2
                infection among frontline workers.\35\ Emerging evidence also suggests
                that vaccinated people who become infected with the SARS-CoV-2 Delta
                variant have potential to be less infectious than infected unvaccinated
                people, thus decreasing transmission risk.\36\ For example, in a study
                of breakthrough infections among health care workers in the
                Netherlands, SARS-CoV-2 infectious virus shedding was lower among
                vaccinated individuals with breakthrough infections than among
                unvaccinated individuals with primary infections.\37\ Fewer infected
                staff and lower transmissibility equates to fewer opportunities for
                transmission to patients, and emerging evidence indicates this is the
                case. The best data come from long term care facilities, as early
                implementation of national reporting requirements have resulted in a
                comprehensive, longitudinal, high quality data set. Data from CDC's
                National Healthcare Safety Network (NHSN) have shown that case rates
                among LTC facility residents are higher in facilities with lower
                vaccination coverage among staff; specifically, residents of LTC
                facilities in which vaccination coverage of staff is 75 percent or
                lower experience higher rates of preventable COVID-19.\38\ Several
                articles published in CDC's Morbidity and Mortality Weekly Reports
                (MMWRs) regarding nursing home outbreaks have also linked the spread of
                COVID-19 infection to unvaccinated health care workers and stressed
                that maintaining a high vaccination rate is important for reducing
                transmission.39 40 41
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                 \35\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
                 \36\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
                 \37\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
                 \38\ https://emergency.cdc.gov/han/2021/han00447.asp.
                 \39\ COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage
                Variant in a Skilled Nursing Facility After Vaccination Program --
                Kentucky, March 2021.'' April 21, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm.
                 \40\ Postvaccination SARS-CoV-2 Infections Among Skilled Nursing
                Facility Residents and Staff Members -- Chicago, Illinois, December
                2020-March 2021.'' April 30, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm.
                 \41\ Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among
                Residents of Two Skilled Nursing Facilities Experiencing COVID-19
                Outbreaks -- Connecticut, December 2020-February 2021.'' March 19,
                2021. Available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm.
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                 There is also some published evidence from other settings that
                suggest similar dynamics can be expected in other health care delivery
                settings. For example, a recent analysis from Yale New Haven Hospital
                (YNHH) found health care units with at least 1 inpatient case of HA-
                COVID-19 had lower staff vaccination rates.\42\ Similarly, a small
                study in Israel demonstrated that transmission of COVID-19 was linked
                to unvaccinated persons. In 37 cases, patients for whom data were
                available regarding the source of infection, the suspected source was
                an unvaccinated person; in 21 patients (57 percent), this person was a
                household member; in 11 cases (30 percent), the suspected source was an
                unvaccinated fellow health care worker or patient.\43\ While similarly
                comprehensive data are not available for all Medicare- and Medicaid-
                certified provider types, the available evidence for ongoing
                healthcare-associated COVID-19 transmission risk is sufficiently
                alarming in and of itself to compel CMS to take action.
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                 \42\ Roberts, S., Aniskiewicz, M., Choi, S., Pettker, C., &
                Martinello, R. (2021). Correlation of healthcare worker vaccination
                on inpatient healthcare-associated COVID-19. Infection Control &
                Hospital Epidemiology, 1-6. Doi:10.1017/ice.2021.414.
                 \43\ Moriah Bergwerk, M.B., B.S., Tal Gonen, B.A., Yaniv Lustig,
                Ph.D., Sharon Amit, M.D., Marc Lipsitch, Ph.D., Carmit Cohen, Ph.D.,
                Michal Mandelboim, Ph.D., Einav Gal Levin, M.D., Carmit Rubin, N.D.,
                Victoria Indenbaum, Ph.D., Ilana Tal, R.N., Ph.D., Malka Zavitan,
                R.N., M.A., et al. Covid-19 Breakthrough Infections in Vaccinated
                Health Care Workers. N Engl J Med 2021; 385:1474-1484. DOI: 10.1056/
                NEJMoa2109072. https://www.nejm.org/doi/full/10.1056/NEJMoa2109072.
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                 The threats that unvaccinated staff pose to patients are not,
                however, limited to SARS-CoV-2 transmission. Unvaccinated staff
                jeopardize patient access to recommended medical care and services, and
                these additional risks to patient health and safety further warrant CMS
                action.
                 Fear of exposure to and infection with COVID-19 from unvaccinated
                health care staff can lead patients to themselves forgo seeking
                medically necessary care. In a small but informative qualitative study
                of 33 home health care workers in New York City, one of the key themes
                to emerge from interviews with those workers was a keen recognition
                that ``providing care to patients placed them in a unique position with
                respect to COVID-19 transmission. They worried . . . about transmitting
                the virus to [their clients].'' They also noted that care for home
                bound clients might involve other health care staff, and they worried
                about ``transmitting COVID-19 . . . to one another.'' \44\
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                 \44\ https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096).
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                 Anecdotal evidence suggests health care consumers have drawn
                similar conclusions--and this, too, has implications for overall health
                and welfare in health care settings. For example, CMS has received
                anecdotal reports suggesting individuals in care are refusing care from
                unvaccinated staff, limiting the extent to which providers and
                suppliers can effectively meet the health care needs of their patients
                and residents. Further, nationwide there are reports of individuals
                avoiding or forgoing health care due to fears of contracting COVID-19
                from health care workers.45 46 47 While avoidance of
                necessary care appears to have abated somewhat since the first months
                of the COVID-19 pandemic, it remains an area of concern for many
                individuals.48 49 Because
                [[Page 61559]]
                unvaccinated staff are at greater risk for infection, they also present
                a threat to health care operations--absenteeism due to COVID-19-related
                exposures or illness can create staffing shortages that disrupt patient
                access to recommended care. Data suggest the current surge in COVID-19
                cases associated with emergence of the Delta variant has exacerbated
                health care staffing shortages. For example, 1 in 5 hospitals report
                that they are currently experiencing a critical staffing shortage.\50\
                Through the week ending September 19, 2021, approximately 23 percent of
                LTC facilities reported a shortage in nursing aides; 21 percent
                reported a shortage of nurses; and 10 to 12 percent reported shortages
                in other clinical and non-clinical staff categories.\51\ And while some
                studies suggest overall staffing levels (as defined by nurse hours per
                resident day) have been relatively stable, this appears to be
                associated with concurrent decreases in patient demand (for example,
                resident census in nursing homes)--decreases that have ramifications
                for patient access to recommended and medically appropriate
                services.52 53 Over half (58 percent) of nursing homes
                participating in a recent survey conducted by the American Health Care
                Association and National Center for Assisted Living (AHCA/NCAL)
                indicated that they are limiting new admissions due to staffing
                shortages.\54\ Similarly, hospital administrators responding to an OIG
                pulse survey conducted during February 22-26, 2021, reported difficulty
                discharging COVID-19 patients to post-acute facilities (for example,
                nursing homes, rehabilitation hospitals, and hospice facilities)
                following the acute stage of the patient's illness. These delays in
                discharge affected available bed space throughout the hospital (for
                example, creating bottlenecks in ICUs and EDs) and delayed patient
                access to specialized post-acute care (such as rehabilitation).\55\ The
                drivers of this staffing crisis are multi-factorial. They include:
                Longstanding shortages in certain fields and professions; prolonged
                physical, mental, and emotional stress and trauma associated with
                responding to the ongoing PHE; and competing personal or professional
                obligations (such as child care) or opportunities (for example, new
                careers). But illnesses and deaths associated with COVID-19 are
                exacerbating staffing shortages across the health care system. Over
                half a million COVID-19 cases and 1,900 deaths among health care staff
                have been reported to CDC since the start of the PHE.\56\ When
                submitting case-level COVID-19 reports, State and territorial
                jurisdictions may identify whether individuals are or are not health
                care workers. Since health care worker status has only been reported
                for a minority of cases (approximately 18 percent), these numbers are
                likely gross underestimates of true burden in this population. COVID-19
                case rates among staff have also grown in tandem with broader national
                incidence trends since the emergence of the Delta variant. For example,
                as of mid-September 2021, COVID-19 cases among LTC facility and ESRD
                facility staff have increased by over 1400 percent and 850 percent,
                respectively, since their lows in June 2021.\57\ Similarly, the number
                of cases among staff for whom case-level data were reported by State
                and territorial jurisdictions to CDC increased by nearly 600 percent
                between June and August 2021.\58\ Vaccination is thus a powerful tool
                for protecting health and safety of patients, and, with the emergence
                and spread of the highly transmissible Delta variant, it has been an
                increasingly critical one to address the extraordinary strain the
                COVID-19 pandemic continues to place on the U.S. health system. While
                COVID-19 cases, hospitalizations, and deaths declined over the first 6
                months of 2021, the emergence of the Delta variant reversed these
                trends.\59\ Between late June 2021 and September 2021, daily cases of
                COVID-19 increased over 1200 percent; new hospital admissions, over 600
                percent; and daily deaths, by nearly 800 percent.\60\ Available data
                also continue to suggest that the majority of COVID-19 cases and
                hospitalizations are occurring among individuals who are not fully
                vaccinated. In a recent study of reported COVID-19 cases,
                hospitalizations, and deaths in 13 U.S. jurisdictions that routinely
                link case surveillance and immunization registry data, CDC found that
                unvaccinated individuals accounted for over 85 percent of all
                hospitalizations in the period between June and July 2021, when Delta
                became the predominant circulating variant.\61\
                ---------------------------------------------------------------------------
                 \45\ J Anxiety Disord. 2020 Oct; 75: 102289. Published online
                2020 Aug 19. Doi: 10.1016/j.janxdis.2020.102289
                 \46\ https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6936a4-H.pdf.
                 \47\ https://www.nahc.org/wp-content/uploads/2020/03/NATIONAL-SURVEY-SHOWS-HOME-HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID-19-AND-CONTINUES-TO-BE-IN-A-FRAGILE-FINANCIAL-STATE.pdf.
                 \48\ https://www.urban.org/sites/default/files/publication/103651/delayed-and-forgone-health-care-for-nonelderly-adults-during-the-covid-19-pandemic_1.pdf.
                 \49\ Gale R, Eberlein S, Fuller G, Khalil C, Almario CV, Spiegel
                BM. Public Perspectives on Decisions About Emergency Care Seeking
                for Care Unrelated to COVID-19 During the COVID-19 Pandemic. JAMA
                Netw Open. 2021;4(8):e2120940. Doi:10.1001/
                jamanetworkopen.2021.20940.
                 \50\ Analysis of data submitted by hospitals through HHS
                Protect; accessed September 20, 2021.
                 \51\ Data reported through CDC's NHSN.
                 \52\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02351.
                 \53\ https://www.npr.org/sections/health-shots/2021/10/14/1043414558/with-hospitals-crowded-from-covid-1-in-5-american-families-delays-health-care.
                 \54\ https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/Workforce-Survey-September2021.pdf.
                 \55\ See HHS OIG reports OEI-09-21-00140 and OEI-06-20-00300,
                both accessed September 26, 2021.
                 \56\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel; accessed September 24, 2021.
                 \57\ Analysis of dialysis facility and nursing home data
                reported through NHSN.
                 \58\ Ibid. 8footnote 56.
                 \59\ https://emergency.cdc.gov/han/2021/han00447.asp.
                 \60\ Internal estimates based on data published at: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html;
                accessed September 24, 2021.
                 \61\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w.
                ---------------------------------------------------------------------------
                 Unfortunately, health care staff vaccination rates remain too low
                in too many health care facilities and regions. For example, national
                COVID-19 vaccination rates for LTC facility, hospital, and ESRD
                facility staff are 67 percent, 64 percent, and 60 percent,
                respectively. Moreover, these averages obscure sizable regional
                differences. LTC facility staff vaccination rates range from lows of 56
                percent to highs of over 90 percent, depending upon the State. Similar
                patterns hold for ESRD facility and hospital staff.62 63 64
                Given slow but steady increases in vaccination rates among staff
                working in these settings over time,\65\ widespread availability of
                vaccines, and targeted efforts to facilitate vaccine access like the
                Federal Retail Pharmacy program,\66\ vaccine hesitancy,\67\ rather than
                other factors (for example, staff turnover) is likely to account for
                suboptimal staff vaccination rates.
                ---------------------------------------------------------------------------
                 \62\ LTC facility rates derived from data reported through CDC's
                NHSN and posted online at the Nursing Home COVID-19 Vaccination Data
                Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html; accessed September 15, 2021.
                 \63\ Dialysis facility rates derived from data reported through
                CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination
                Data Dashboard: https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html; accessed September 15, 2021.
                 \64\ Hospital data come from unpublished analyses of data
                reported to HHS and posted on HHS Protect.
                 \65\ Ibid. footnotes 62-64.
                 \66\ https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html.
                 \67\ https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html.
                ---------------------------------------------------------------------------
                 While a significant number of health care staff have been infected
                with SARS-CoV-2,\68\ evidence indicates their infection-induced
                immunity, also called ``natural immunity,'' is not equivalent to
                receiving the COVID-19 vaccine. Available evidence indicates that
                COVID-19 vaccines offer better protection than infection-induced
                immunity alone and that vaccines, even after prior infection, help
                prevent
                [[Page 61560]]
                reinfections.\69\ Consequently, CDC recommends that all people be
                vaccinated, regardless of their history of symptomatic or asymptomatic
                SARS-CoV-2 infection.\70\
                ---------------------------------------------------------------------------
                 \68\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
                 \69\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e1.htm?s_cid=mm7032e1_w.
                 \70\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination.
                ---------------------------------------------------------------------------
                 Further, the risks of unvaccinated health care staff may
                disproportionately impact communities who experience social risk
                factors and populations described under Executive Order 13985,
                Advancing Racial Equity and Support for Underserved Communities Through
                the Federal Government, including members of racial and ethnic
                communities; individuals with disabilities; individuals with limited
                English proficiency; Lesbian, Gay, Bisexual, Transgender, and Queer
                (LGBTQ+) individuals; individuals living in rural areas; and others
                adversely affected by persistent poverty or inequality. CDC data show
                that across the U.S., physicians and advanced practice providers have
                significantly higher vaccination rates than aides.71 72
                Among aides, lower vaccination coverage was observed in those
                facilities located in zip codes where communities experience greater
                social risk factors. The finding that vaccination coverage among aides
                was lower among those working at LTC facilities located in zip code
                areas with higher social vulnerability is consistent with an earlier
                analysis of overall county-level vaccination coverage by indices of
                social vulnerability.\73\ CDC notes that together, these data suggest
                that vaccination disparities among job categories are likely to mirror
                social disparities as well as disparities in surrounding communities.
                In addition, nurses and aides who may have the most patient contact
                have the lowest rates of vaccination coverage among health care staff.
                COVID-19 outbreaks have occurred in LTC facilities in which residents
                were highly vaccinated, but transmission occurred through unvaccinated
                staff members.\74\ These findings have implications regarding
                occupational safety and health outcome equity--national data indicates
                that aides in nursing homes are disproportionately women and members of
                racial and ethnic communities with lower hourly wages than physicians
                and advance practice clinicians,\75\ and are also more likely to have
                underlying conditions that put them at risk for adverse outcomes from
                COVID-19.\76\ Ensuring full vaccination coverage across health care
                settings is critical to addressing these disparities among health care
                workers, particularly those from communities who experience social
                risk, and to equitably protecting individuals CMS serves from
                unnecessary and significant harm associated with COVID-19 cases and the
                ongoing pandemic.
                ---------------------------------------------------------------------------
                 \71\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm.
                 \72\ https://doi.org/10.7326/M21-3150.
                 \73\ Hughes MM, Wang A, Grossman MK, et al. County-level COVID-
                19 vaccination coverage and social vulnerability--United States,
                December 14, 2020-March 1, 2021. MMWR Morb Mortal Wkly Rep
                2021;70:431-6. https://doi.org/10.15585/mmwr.mm7012e1external icon
                PMID:33764963external icon.
                 \74\ Cavanaugh AM, Fortier S, Lewis P, et al. COVID-19 outbreak
                associated with a SARS-CoV-2 R.1 lineage variant in a skilled
                nursing facility after vaccination program--Kentucky, March 2021.
                MMWR Morb Mortal Wkly Rep 2021;70:639-43. https://doi.org/10.15585/mmwr.mm7017e2external icon PMID:33914720external icon.
                 \75\ Bureau of Labor Statistics. May 2020 national occupational
                employment and wage estimates. Washington, DC: US Department of
                Labor, Bureau of Labor Statistics; 2021. Accessed May 1, 2021.
                https://www.bls.gov/oes/current/oes_nat.htm#00-0000externalicon.
                 \76\ Silver SR, Li J, Boal WL, Shockey TL, Groenewold MR.
                Prevalence of underlying medical conditions among selected essential
                critical infrastructure workers--behavioral risk factor surveillance
                system, 31 states, 2017-2018. MMWR Morb Mortal Wkly Rep
                2020;69:1244-9. https://doi.org/10.15585/mmwr.mm6936a3external icon
                PMID:32914769external icon.
                ---------------------------------------------------------------------------
                 It is essential to reduce the transmission and spread of COVID-19,
                and vaccination is central to any multi-pronged approach for reducing
                health system burden, safeguarding health care workers and the people
                they serve, and ending the COVID-19 pandemic. Currently FDA-approved
                and FDA-authorized vaccines in use in the U.S. are both safe and highly
                effective at protecting vaccinated people against symptomatic and
                severe COVID-19.\77\ Higher rates of vaccination, especially in health
                care settings, will contribute to a reduction in the transmission of
                SARS-CoV-2 and associated morbidity and mortality across providers and
                communities, contributing to maintaining and increasing the amount of
                healthy and productive health care staff, and reducing risks to
                patients, resident, clients, and PACE program participants.
                ---------------------------------------------------------------------------
                 \77\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. Accessed 10/14/2021.
                ---------------------------------------------------------------------------
                 In light of our responsibility to protect the health and safety of
                individuals providing and receiving care and services from for
                Medicare- and Medicaid-certified providers and suppliers, and CMS's
                broad statutory authority to establish health and safety regulations,
                we are compelled to require staff vaccinations for COVID-19 in these
                settings. For these reasons, we are issuing this IFC based on these
                authorities and in accordance with established rule making processes.
                Specifically, sections 1102 and 1871 of the Social Security Act (the
                Act) grant the Secretary of Health and Human Services authority to make
                and publish such rules and regulations, not inconsistent with the Act,
                as may be necessary to the efficient administration of the functions
                with which the Secretary is charged under this Act and as may be
                necessary to carry out the administration of the insurance programs
                under the Act. The discussions of the provider- and supplier-specific
                provisions in section II. of this IFC set out the specific authorities
                for each provider or supplier type. Provider and supplier compliance
                with the Federal rules issued under these statutory authorities are
                mandatory for participation in the Medicare and Medicaid programs.
                 To the extent a court may enjoin any part of the rule, the
                Department intends that other provisions or parts of provisions should
                remain in effect. Any provision of this section held to be invalid or
                unenforceable by its terms, or as applied to any person or
                circumstance, shall be construed so as to continue to give maximum
                effect to the provision permitted by law, unless such holding shall be
                one of utter invalidity or unenforceability, in which event the
                provision shall be severable from this section and shall not affect the
                remainder thereof or the application of the provision to persons not
                similarly situated or to dissimilar circumstances.
                A. Regulatory Responses to the PHE
                1. Waivers
                 CMS and other Federal agencies have taken many actions and
                exercised extensive regulatory flexibilities to help health care
                providers contain the spread of SARS-CoV-2. When the President declares
                a national emergency under the National Emergencies Act or an emergency
                or disaster under the Stafford Act, CMS is empowered to take proactive
                steps by waiving certain CMS regulations, as authorized under section
                1135 of the Act (``1135 waivers''). CMS may also grant certain
                flexibilities to skilled nursing facilities (SNFs) under Medicare, as
                authorized separately under section 1812(f) of the Act (``1812(f)
                flexibilities''). The 1135 waivers and 1812(f) flexibilities allowed us
                to rapidly expand efforts to help control the spread of SARS-CoV-2. We
                have issued PHE waivers for most Medicare- and Medicaid-certified
                [[Page 61561]]
                providers and suppliers, with the goal of supporting each facility's
                operational flexibility while preserving health and safety and core
                health care functions.
                2. Rulemaking
                 Since the onset of the PHE, we have issued five IFCs to help
                contain the spread of SARS-CoV-2. On April 6, 2020, we issued an IFC
                (Medicare and Medicaid Programs; Policy and Regulatory Revisions in
                Response to the COVID-19 Public Health Emergency (85 FR 19230 through
                19292), which established that certain requirements for face-to-face/
                in-person encounters will not apply during the PHE for COVID-19
                effective for claims with dates of service on or after March 1, 2020,
                and for the duration of the PHE for COVID-19. On May 8, 2020, we issued
                a second IFC (Medicare and Medicaid Programs, Basic Health Program, and
                Exchanges; Additional Policy and Regulatory Revisions in Response to
                the COVID-19 Public Health Emergency and Delay of Certain Reporting
                Requirements for the Skilled Nursing Facility Quality Reporting Program
                (85 FR 27550 through 27629)) (``May 8, 2020 COVID-19 IFC''). This
                second IFC contained additional information on changes Medicare made to
                existing regulations to provide flexibilities for Medicare
                beneficiaries and providers to respond effectively to the PHE for
                COVID-19. On September 2, 2020, we issued a third IFC (Medicare and
                Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA),
                and Patient Protection and Affordable Care Act; Additional Policy and
                Regulatory Revisions in Response to the COVID-19 Public Health
                Emergency (85 FR 54820 through 54874)) (``September 2, 2020 COVID-19
                IFC''), that included new requirements for hospitals and CAHs to report
                data in accordance with a frequency and in a standardized format as
                specified by the Secretary during the PHE for COVID-19. On November 6,
                2020, we issued a fourth IFC (Additional Policy and Regulatory
                Revisions in Response to the COVID-19 Public Health Emergency (85 FR
                71142 through 71205)). This IFC discussed CMS's implementation of
                section 3713 of the Coronavirus Aid, Relief, and Economic Security Act
                (CARES Act), which established Medicare Part B coverage and payment for
                Coronavirus Disease 2019 (COVID-19) vaccine and its administration.
                This IFC implemented requirements in the CARES Act that providers of
                COVID-19 diagnostic tests make public their cash prices for those tests
                and established an enforcement scheme to enforce those requirements.
                This IFC also established an add-on payment for cases involving the use
                of new COVID-19 treatments under the Medicare Inpatient Prospective
                Payment System (IPPS). Most recently, on May 13, 2021, we issued the
                fifth IFC (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 (86 FR 26306)) (``May 13, 2021 COVID-19
                IFC''), that revised the infection control requirements that LTC
                facilities and ICFs-IID must meet to participate in the Medicare and
                Medicaid programs.
                 OSHA has also engaged in rulemaking in response to the PHE for
                COVID-19. On June 21, 2021, OSHA issued the COVID-19 Healthcare
                Emergency Temporary Standard (ETS) at 29 CFR 1910 subpart U (86 FR
                32376) to protect health care and health care support service workers
                from occupational exposure to COVID-19.\78\ Health care employers
                covered by the ETS must develop and implement a COVID-19 plan for each
                workplace to identify and control COVID-19 hazards in the workplace and
                implement requirements to reduce transmission of SARS-CoV-2 in their
                workplaces related to the following: (1) Patient screening and
                management, (2) standard and transmission-based precautions, (3)
                personal protective equipment (including facemasks, and respirators),
                (4) controls for aerosol-generating procedures performed on persons
                with suspected or confirmed COVID-19, (5) physical distancing, (6)
                physical barriers, (7) cleaning and disinfection, (8) ventilation, (9)
                health screening and medical management, (10) training, (11) anti-
                retaliation, (12) recordkeeping, and, (13) reporting. In addition, the
                ETS requires covered employers to support COVID-19 vaccination for each
                employee by providing reasonable time and paid leave for employees to
                receive vaccines and recover from side effects.
                ---------------------------------------------------------------------------
                 \78\ https://www.osha.gov/coronavirus/ets. Accessed 10/6/2021.
                ---------------------------------------------------------------------------
                 The ETS generally applies to all workplace settings where any
                employee provides health care services or health care support services;
                however, because the ETS targets settings where care is provided for
                individuals with known or suspected COVID-19, the rule contains several
                exceptions. The ETS does not apply to: (1) Provision of first aid by
                any employee who is not a licensed health care provider, (2) dispensing
                of prescriptions by pharmacists in retail settings, (3) non-hospital
                ambulatory care settings where all non-employees are screened prior to
                entry, and people with suspected or confirmed COVID-19 are not
                permitted to enter, (4) well-defined hospital ambulatory care settings
                where all employees are fully vaccinated, all non-employees are
                screened prior to entry, and people with suspected or confirmed COVID-
                19 are not permitted to enter, (5) home health care settings where all
                employees are fully vaccinated, all non-employees are screened prior to
                entry, and people with suspected or confirmed COVID-19 are not present,
                (6) health care support services not performed in a health care setting
                (for example, offsite laundry, off-site medical billing), and (7)
                telehealth services performed outside of a setting where direct patient
                care occurs. Furthermore, in well-defined areas where there is no
                reasonable expectation that any person with suspected or confirmed
                COVID-19 will be present, the ETS exempts fully vaccinated workers from
                masking, distancing, and barrier requirements.
                 Moreover, the ETS requires employers to immediately remove
                employees from the workplace if they (1) have tested positive for
                COVID-19, (2) have been diagnosed with COVID-19 by a licensed health
                care provider, (3) have been advised by a licensed health care provider
                that they are suspected to have COVID-19, or (4) are experiencing
                certain symptoms (defined as either loss of taste and/or smell with no
                other explanation, or fever of at least 100.4 degrees Fahrenheit and
                new unexplained cough associated with shortness of breath). Employers
                must also immediately remove an employee who was not wearing a
                respirator and any other required PPE and had been in close contact
                with a COVID-19 positive person in the workplace. However, removal from
                the workplace due to instances of close contact exposure in the
                workplace is not required for asymptomatic employees who either had
                COVID-19 and recovered with the last 3 months, or have been fully
                vaccinated (that is, 2 or more weeks have passed since the final dose).
                 Complementary to the OSHA ETS, this interim final rule requires
                certain providers and suppliers participating in Medicare and Medicaid
                programs to ensure staff are fully vaccinated for COVID-19, unless
                exempt, because vaccination of staff is necessary for the health and
                safety of individuals to whom care and services are furnished. Health
                care staff are at high risk for SARS-CoV-2 exposure, the virus that
                causes COVID-19, due to interactions with patients and individuals in
                the
                [[Page 61562]]
                community.\79\ Receiving a complete primary vaccination series reduces
                the risk of COVID-19 by 90 percent or more thereby inhibiting the
                spread of disease to others.\80\ Furthermore, a COVID-19 vaccination
                requirement reduces the likelihood of medical removal of health care
                staff from the workplace, as required by the OSHA COVID-19 Healthcare
                ETS. This is yet another way in which this interim final rule protects
                the individuals who receive services from the providers and suppliers
                to whom the rule applies by minimizing unpredictable disruptions to
                operations and care.
                ---------------------------------------------------------------------------
                 \79\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6938a3.htm?s_cid=mm6938a3_w. Accessed10/16/2021.
                 \80\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html. Accessed 10/16/2021.
                ---------------------------------------------------------------------------
                 OSHA is the Federal agency responsible for setting and enforcing
                standards to ensure safe and healthy working conditions for workers.
                The COVID-19 Healthcare ETS addresses protections for health care and
                health care support service workers from the grave danger of COVID-19
                exposure in certain workplaces. CMS is the Federal agency responsible
                for establishing health and safety regulations for Medicare- and
                Medicaid-certified providers and suppliers. Hence, we are establishing
                a final rule requiring COVID-19 vaccination of staff to safeguard the
                health and safety of patients, residents, clients, and PACE program
                participants who receive care and services from those providers and
                suppliers. Providers and suppliers may be covered by both the OSHA ETS
                and our interim final rule. Although the requirements and purpose of
                each regulation text are different, they are complementary.
                B. COVID-19 Vaccine Development and Approval
                 FDA analysis has shown that all of the currently approved or
                authorized vaccines are safe and CDC reports that over 408 million
                doses of the vaccine have been given through October 18, 2021.\81\
                Bringing a new vaccine to the public involves many steps, including
                vaccine development, clinical trials, and U.S. Food and Drug
                Administration (FDA) authorization or approval. While COVID-19 vaccines
                were developed rapidly, all steps have been taken to ensure their
                safety and effectiveness. Scientists have been working for many years
                to develop vaccines against coronaviruses, such as those that cause
                severe acute respiratory syndrome (SARS) and Middle East respiratory
                syndrome (MERS). SARS-CoV-2, the virus that causes COVID-19, is related
                to these other coronaviruses and the knowledge that was gained through
                past research on coronavirus vaccines helped speed up the initial
                development of the current COVID-19 vaccines. After initial
                development, vaccines go through three phases of clinical trials to
                make sure they are safe and effective. For other vaccines routinely
                used in the U.S., the three phases of clinical trials are performed one
                at a time. During the development of COVID-19 vaccines, these phases
                overlapped to speed up the process so the vaccines could be used as
                quickly as possible to control the pandemic. No trial phases were
                skipped.\82\
                ---------------------------------------------------------------------------
                 \81\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/
                safety-of-
                vaccines.html#:~:text=Millions%20of%20people%20in%20the,monitoring%20
                in%20US%20history.
                 \82\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/distributing/steps-ensure-safety.html.
                ---------------------------------------------------------------------------
                 All COVID-19 vaccines currently licensed (approved) \83\ or
                authorized for use in the U.S. were tested in clinical trials involving
                tens of thousands of people. FDA evaluated all of the information
                submitted to it in requests for Emergency Use Authorization (EUA) for
                the authorized COVID-19 vaccines and, for the Comirnaty COVID-19
                Vaccine, in a Biologics License Application (the conventional path to
                FDA approval of a vaccine). FDA determined that these vaccines meet
                FDA's standards for safety, effectiveness, and manufacturing quality
                needed to support emergency use authorization and licensure, as
                applicable. The clinical trials included participants of different
                races, ethnicities, and ages, including adults over the age of 65.\84\
                Because COVID-19 continues to be widespread, researchers have been able
                to conduct vaccine clinical trials more quickly than if the disease
                were less common. Side effects following vaccination are dependent on
                the specific vaccine that an individual receives, and the most common
                include pain, redness, and swelling at the injection site, tiredness,
                headache, muscle pain, nausea, vomiting, fever, and chills.\85\ After a
                review of all available information, the Advisory Committee on
                Immunization Practices (ACIP) and CDC have concluded the lifesaving
                benefits of COVID-19 vaccination outweigh the risks or possible side
                effects.\86\
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                 \83\ ``Licensed'' is the statutory term under section 351 of the
                Public Health Service Act for what is commonly referred to as
                approval of a biological product. For purposes of this rulemaking,
                the terms `approved' or `licensed' and `approval' or `licensure' are
                being used interchangeably with respect to COVID-19 vaccines.
                 \84\ https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/.
                 \85\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html.
                 \86\ See Centers for Disease Control and Prevention. Benefits of
                Getting a COVID-19 Vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. Updated January 5, 2021.
                Accessed January 14, 2021.
                ---------------------------------------------------------------------------
                 The COVID-19 vaccines currently licensed or authorized for use in
                the U.S. are generally administered as either a single dose or a two-
                dose series given at least 21 or 28 days apart. Following completion of
                that primary series, a subsequent dose or doses may be recommended for
                one of two purposes. In the first instance, an additional dose of
                vaccine is administered when the immune response following a primary
                vaccine series is likely to be insufficient. In other words, the
                additional dose augments the original primary series. Currently, the
                EUA for the Moderna mRNA COVID-19 vaccine has been amended to include
                the use of a third primary series dose (that is, ``additional dose'')
                in certain immunocompromised individuals 18 years of age or older.
                Similarly, the EUA for the Pfizer BioNTech mRNA COVID-19 vaccine has
                been amended to include the use of an additional, or third primary
                series, dose in certain immunocompromised individuals 12 years of age
                and older.
                 In the second instance, a booster dose of vaccine is administered
                when the initial immune response to a primary vaccine series is likely
                to have waned over time. In other words, although an adequate immune
                response occurred after the primary vaccine series, over time, immunity
                decreases.87 88 89 On September 22, 2021, the FDA amended
                the EUA for the Pfizer BioNTech mRNA COVID-19 vaccine to allow for use
                of a single booster dose in certain individuals, to be administered at
                least 6 months after completion of the primary series. Specifically,
                this booster dose is authorized for individuals 65 years of age and
                older, individuals 18 through 64 years of age at high risk of severe
                COVID-19, and individuals 18 through 64 years of age whose frequent
                institutional or occupational exposure to SARS-CoV-2 puts them at high
                risk of serious complications of COVID-19 including severe COVID-
                19.\90\
                [[Page 61563]]
                Throughout this rule, we will use the terms ``additional dose'' and
                ``booster'' to differentiate between the two use cases outlined above.
                ---------------------------------------------------------------------------
                 \87\ Summaries of evidence presented to CDC's Advisory Council
                on Immunization Practices available at https://www.cdc.gov/vaccines/acip/meetings/slides-2021-09-22-23.html.
                 \88\ https://www.nejm.org/doi/full/10.1056/NEJMoa2114583.
                 \89\ https://www.medrxiv.org/content/10.1101/2020.10.26.20219725v1.
                 \90\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine.
                ---------------------------------------------------------------------------
                 Every person who receives a COVID-19 vaccine receives a vaccination
                record card noting which vaccine and the dose that was received.
                Vaccine materials specific to each vaccine are located on CDC \91\ and
                FDA \92\ websites. CDC has posted a collection of informational
                toolkits for specific communities and settings at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html. These toolkits provide
                staff, facility administrators, clinical leadership, caregivers, and
                health care consumers with information and resources.
                ---------------------------------------------------------------------------
                 \91\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html.
                 \92\ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
                ---------------------------------------------------------------------------
                 While we are not requiring participation, we encourage staff who
                use smartphones to use CDC's smartphone-based tool called ``v-safe
                After Vaccination Health Checker'' (v-safe) \93\ to self-report on
                one's health after receiving a COVID-19 vaccine. V-safe is a program
                that differs from the Vaccine Adverse Event Reporting System (VAERS),
                which we discuss in section I.C. of this rule. Individuals may report
                adverse reactions to a COVID-19 vaccine to either program. Enrollment
                in v-safe allows any participating vaccine recipient to directly and
                efficiently report to CDC how they are feeling after receiving a
                specific vaccine, including any problems or adverse reactions. When an
                individual receives the vaccine, they should also receive a v-safe
                information sheet telling them how to enroll in v-safe or they can
                register at http://www.vsafe.cdc.gov. Individuals who enroll will
                receive regular text messages providing links to surveys where they can
                report any problems or adverse reactions after receiving a COVID-19
                vaccine, as well as receive ``check-ins,'' and reminders for a second
                dose if applicable.\94\ We note again that participation in v-safe is
                not mandatory, and further that staff participation and any health
                information provided is not traced to or shared with employers.
                ---------------------------------------------------------------------------
                 \93\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html.
                 \94\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
                ---------------------------------------------------------------------------
                 Based on current CDC guidance,\95\ individuals are considered fully
                vaccinated for COVID-19 14 days after receipt of either a single-dose
                vaccine (Janssen/Johnson & Johnson) or the second dose of a two-dose
                primary vaccination series (Pfizer-BioNTech/Comirnaty or Moderna). This
                guidance can also be applied to COVID-19 vaccines listed for emergency
                use by the World Health Organization (WHO) and some vaccines used in
                COVID-19 clinical trials conducted in the U.S. These circumstances are
                addressed in more detail in section I.C. of this IFC. To improve immune
                response for those individuals with moderately to severely compromised
                immune systems who receive the Pfizer-BioNTech Vaccine, Comirnaty, or
                Moderna Vaccine, the CDC advises an additional (third) dose of an mRNA
                COVID-19 vaccine after completing the primary vaccination series.\96\
                In addition, certain individuals who received the Pfizer-BioNTech
                COVID-19 Vaccine may receive a booster dose at least 6 months after
                completing the primary vaccination series.\97\
                ---------------------------------------------------------------------------
                 \95\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. Accessed 10/16/2021.
                 \96\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html. Accessed 10/14/2021.
                 \97\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html. Accessed 10/16/2021.
                ---------------------------------------------------------------------------
                 This IFC requires Medicare- and Medicaid-certified providers and
                suppliers to ensure that staff are fully vaccinated for COVID-19,
                unless the individual is exempted. Consistent with CDC guidance, we
                consider staff fully vaccinated if it has been 2 or more weeks since
                they completed a primary vaccination series for COVID-19. We define
                completion of a primary vaccination series as having received a single-
                dose vaccine or all doses of a multi-dose vaccine. Currently, CDC
                guidance does not include either the additional (third) dose of an mRNA
                COVID-19 vaccine for individuals with moderately or severely
                immunosuppression or the booster dose for certain individuals who
                received the Pfizer-BioNTech Vaccine in their definition of fully
                vaccinated.\98\ Therefore, for purposes of this IFC, neither additional
                (third) doses nor booster doses are required. The OSHA Emergency
                Temporary Standard for Healthcare discussed in section I.A.2. of this
                IFC also defines fully vaccinated in accordance with CDC guidance.
                Hence, definitions of fully vaccinated are consistent among the
                requirements in these regulations.
                ---------------------------------------------------------------------------
                 \98\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. Accessed 10/16/2021.
                ---------------------------------------------------------------------------
                C. Administration of Vaccines Outside the U.S., Listed for Emergency
                Use by the WHO, Heterologous Primary Series, and Clinical Trials
                 We expect the majority of staff will likely receive a COVID-19
                vaccine authorized for emergency use by the FDA or licensed by the FDA.
                Currently, this would include the authorized Pfizer-BioNTech
                (interchangeable with the licensed Comirnaty vaccine made by Pfizer for
                BioNTech), Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines.
                We also expect COVID-19 vaccine administration will likely occur within
                the U.S. for the majority of staff. However, some staff may receive FDA
                approved or authorized COVID-19 vaccines outside of the U.S., vaccines
                administered outside of the U.S. that are listed by the WHO for
                emergency use that are not approved or authorized by the FDA, or
                vaccines during their participation in a clinical trial at a site in
                the U.S. For these staff, we defer to CDC guidance for COVID-19
                vaccination briefly discussed here. For more information, providers and
                suppliers should consult the CDC website at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#.
                 Repeat vaccine doses are not recommended by CDC for individuals who
                previously completed the primary series of a vaccine approved or
                authorized by the FDA, even if administration of the vaccine occurred
                outside of the U.S. Individuals who receive a COVID-19 vaccine for
                which two doses are required to complete the primary vaccination series
                should adhere as closely as possible to the recommended intervals.
                Following completion of their second dose, certain individuals who had
                received the Pfizer-BioNTech COVID-19 vaccine may receive a booster
                dose at least 6 months after completion of the primary vaccination
                series. Moderately to severely immunocompromised individuals who have
                received 2 doses of an mRNA vaccine may receive a third dose at least
                28 days after the second dose. Vaccine administration may occur inside
                or outside of the U.S.
                 Furthermore, the WHO maintains a list of COVID-19 vaccines for
                emergency use.\99\ The CDC advises that doses of an FDA approved or
                authorized COVID-19 vaccine are not recommended for individuals who
                have previously completed the primary series of a vaccine listed for
                emergency use by
                [[Page 61564]]
                the WHO. For those who have not completed the primary series of a
                vaccine listed for emergency use by the WHO, they may receive an FDA
                approved or authorized COVID-19 vaccination series. In addition,
                individuals who have received a COVID-19 vaccine that is neither
                approved nor authorized by the FDA, nor listed on the WHO emergency use
                list, may receive an FDA approved or authorized vaccination series. The
                CDC guidelines recommend at least 28 days between administration of an
                FDA licensed or authorized vaccine, a non-FDA approved or authorized
                vaccine, and a vaccine listed by WHO for emergency use.
                ---------------------------------------------------------------------------
                 \99\ https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines. Accessed September 14, 2021.
                ---------------------------------------------------------------------------
                 For the completion of the primary series of COVID-19 vaccination,
                individuals should generally avoid using heterologous vaccines--meaning
                receiving doses of different vaccines--to complete a primary COVID-19
                vaccination series. Nevertheless, CDC does recognize that, in certain
                situations (for example, when the vaccine product given for the first
                dose cannot be determined or is no longer available), a different
                vaccine may be used to complete the primary COVID-19 vaccination
                series. Accordingly, staff may be considered compliant with the
                requirements within this regulation if they have received any
                combination of two doses of a vaccine licensed or authorized by the FDA
                or listed on the WHO emergency use list as part of a two-dose series.
                Of note, the recommended interval between the first and second doses of
                a vaccine licensed or authorized by FDA, or listed on the WHO emergency
                use list, varies by vaccine type. For interpretation of vaccination
                records and compliance with this rule, people who received a
                heterologous primary series (with any combination of FDA-authorized,
                FDA-approved, or WHO EUL-listed products) can be considered fully
                vaccinated if the second dose in a two dose heterologous series must
                have been received no earlier than 17 days (21 days with a 4 day grace
                period) after the first dose.\100\ Because the science and clinical
                recommendations are evolving rapidly, we refer individuals to CDC's
                Interim Public Health Recommendations for Fully Vaccinated People for
                additional details.
                ---------------------------------------------------------------------------
                 \100\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.
                ---------------------------------------------------------------------------
                 Some staff may receive COVID-19 vaccines due to their participation
                in a clinical trial at a site in the U.S. Repeat vaccine doses are not
                recommended by CDC for participants in a clinical trial who previously
                completed the primary series of a vaccine approved or authorized by
                FDA, or listed for emergency use by the WHO. Likewise, for individuals
                who participated in a clinical trial at a site in the U.S. and received
                the full series of an ``active'' vaccine candidate (not placebo) and
                ``vaccine efficacy has been independently confirmed (for example, by a
                data and safety monitoring board),'' CDC does not recommend repeat
                doses.\101\
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                 \101\ https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html# Accessed 9/14/2021.
                ---------------------------------------------------------------------------
                D. FDA Emergency Use Authorization (EUA) and Licensure of COVID-19
                Vaccines
                 The FDA provides scientific and regulatory advice to vaccine
                developers and undertakes a rigorous evaluation of the scientific
                information it receives from all phases of clinical trials; such
                evaluation continues after a vaccine has been licensed by FDA or
                authorized for emergency use. On August 23, 2021, FDA licensed the
                first COVID-19 vaccine. The vaccine had been known as the Pfizer-
                BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, for
                the prevention of COVID-19 in individuals 16 years of age and
                older.\102\ The vaccine continues to be available in the U.S. under
                EUA, including for individuals 12 through 15 years of age. This EUA has
                been amended to allow for the use of a third dose for certain
                immunocompromised individuals 12 years of age and older. This EUA has
                also been amended to allow for use of a single booster dose in certain
                individuals. FDA has issued EUAs for two additional vaccines for the
                prevention of COVID-19, one for the Moderna COVID-19 vaccine (December
                18, 2020) (indicated for use in individuals 18 years of age and older),
                and the other for Janssen (Johnson & Johnson) COVID-19 Vaccine
                (February 27, 2021) (indicated for use in individuals 18 years of age
                and older). The EUA for the Moderna COVID-19 vaccine has been amended
                to allow for the use of a third dose in certain immunocompromised
                individuals. Package inserts and fact sheets for health care providers
                administering COVID-19 vaccines are available for each licensed and
                authorized vaccine from the FDA.103 104 105
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                 \102\ https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine Accessed 10/14/2021.
                 \103\ Pfizer Fact Sheet--https://www.fda.gov/media/144413/download.
                 \104\ Moderna Fact Sheet--https://www.fda.gov/media/144637/download.
                 \105\ Janssen Fact Sheet--https://www.fda.gov/media/146304/download.
                ---------------------------------------------------------------------------
                 Section 564 of the Federal Food, Drug, and Cosmetic Act authorizes
                FDA to issue EUAs. An EUA is a mechanism to facilitate the availability
                and use of medical countermeasures, including vaccines, during public
                health emergencies, such as the current COVID-19 pandemic. FDA may
                authorize certain unapproved medical products or unapproved uses of
                approved medical products to be used in an emergency to diagnose,
                treat, or prevent serious or life-threatening diseases or conditions
                caused by threat agents when certain criteria are met, including there
                are no adequate, approved, and available alternatives.\106\
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                 \106\ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
                ---------------------------------------------------------------------------
                 The safety of the approved and authorized COVID-19 vaccines is
                closely monitored. VAERS is a safety and monitoring system that can be
                used by anyone to report adverse events after vaccines. For COVID-19
                vaccines, vaccination providers and licensed and authorized vaccine
                manufacturers, must report select adverse events to VAERS following
                receipt of COVID-19 vaccines (including serious adverse events, cases
                of multisystem inflammatory syndrome (MIS), and COVID-19 cases that
                result in hospitalization or death).\107\ Providers also must adhere to
                any revised safety reporting requirements. FDA's website includes
                letters of authorization and fact sheets and these documents should be
                checked for any updates that may occur. Other adverse events following
                vaccination may also be reported to VAERS. Additionally, adverse events
                are also monitored through electronic health record- and claims-based
                systems (through CDC's Vaccine Safety Datalink and FDA's Biologics
                Effectiveness and Safety System (BEST)).
                ---------------------------------------------------------------------------
                 \107\ Department of Health and Human Services. VAERS--Vaccine
                Adverse Event Reporting System. Accessed at https://vaers.hhs.gov/.
                Accessed on January 26, 2021.
                ---------------------------------------------------------------------------
                 FDA is closely monitoring the safety of the COVID-19 vaccines both
                authorized for emergency use and licensed use. Vaccination providers
                are responsible for mandatory reporting to VAERS of certain adverse
                events as listed on the Health Care Provider Fact Sheets for the
                authorized COVID-19 vaccines and for Comirnaty.
                 Vaccine safety is critically important for all vaccination
                programs. Side effects following vaccinations often include swelling,
                redness, and pain at the injection site; flu-like symptoms; headache;
                and nausea; all typically of
                [[Page 61565]]
                short duration.\108\ Serious adverse reactions also have been reported
                following COVID-19 vaccines; however, they are rare.109 110
                For example, it is estimated that anaphylaxis following the mRNA COVID-
                19 vaccines occurs in 2-5 individuals per million vaccinated (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html).
                For these individuals, another shot of an mRNA COVID-19 vaccine is not
                recommended,\111\ and they should discuss receiving a different type of
                COVID-19 vaccine with their health care practitioner.\112\ Other rare
                serious adverse reactions that have been reported to occur following
                COVID-19 vaccines include thrombosis with thrombocytopenia syndrome
                (TTS) following the Janssen COVID-19 vaccine and myocarditis and/or
                pericarditis following the mRNA COVID-19 vaccines (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html). In the face
                of the COVID-19 pandemic, global researchers were able to build upon
                decades of vaccine development, research, and use to produce safe
                vaccines that have been highly effective in protecting individuals from
                COVID-19. From December 14, 2020, through October 12, 2021, over 403
                million doses of COVID-19 vaccine have been administered in the U.S.
                https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. ``CDC recommends everyone 12 years and older get
                vaccinated as soon as possible to help protect against COVID-19 and the
                related, potentially severe complications that can occur.'' \113\ They
                state that the ``potential benefits of COVID-19 vaccination outweigh
                the known and potential risks, including the possible risk of
                myocarditis or pericarditis.'' \114\
                ---------------------------------------------------------------------------
                 \108\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. Accessed 10/17/2021.
                 \109\ Ibid.
                 \110\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. Access 10/17/2021.
                 \111\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. Accessed 10/17/2021.
                 \112\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html#anchor_1624541541034.
                Accessed 10/17/2021.
                 \113\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html. Accessed 10/17/2021.
                 \114\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. Accessed 10/17/2021.
                ---------------------------------------------------------------------------
                E. COVID-19 Vaccine Effectiveness
                 COVID-19 vaccines currently approved or authorized by FDA are
                highly effective in preventing serious outcomes of COVID-19, including
                severe disease, hospitalization, and death.\115\ Moreover, available
                evidence suggests that these vaccines offer protection against known
                variants, including the Delta variant (B.1.617.2), particularly against
                hospitalization and death.116 117 Furthermore, a recent
                study found that, between December 14, 2020, and August 14, 2021, full
                vaccination with COVID-19 vaccines was 80 percent effective in
                preventing RT-PCR-confirmed SARS-CoV-2 infection among frontline
                workers, further affirming the highly protective benefit of full
                vaccination up to and through the 2021 summer COVID-19 pandemic waves
                in the U.S.\118\ While vaccine effectiveness point estimates did
                decline over the course of the study as the Delta variant became
                predominant, the protection afforded by vaccination remained
                significant, underscoring the continued importance and benefits of
                COVID-19 vaccination.\119\
                ---------------------------------------------------------------------------
                 \115\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html.
                 \116\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e2.htm?s_cid=mm7034e2_w.
                 \117\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm?s_cid=mm7034e1_w.
                 \118\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm#contribAff.
                 \119\ https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11504:cdc%20delta%20variant%20vaccine%20effectiveness:sem.ga:p:RG:GM:gen:PTN:FY21.
                ---------------------------------------------------------------------------
                 Like most vaccines, COVID-19 vaccines are not 100 percent effective
                in preventing COVID-19. Consequently, some ``breakthrough'' cases are
                expected and, as the number of people who have completed a primary
                vaccination series and are considered fully vaccinated for COVID-19
                increases, breakthrough COVID-19 cases will also increase
                commensurately. However, the risk of developing COVID-19, including
                severe illness, remains much higher for unvaccinated than vaccinated
                people. Vaccinated people with a breakthrough COVID-19 case are less
                likely to develop serious disease, be hospitalized, and die than those
                who are unvaccinated and get COVID-19.\120\ The combined protections
                offered by vaccination and ongoing implementation of other infection
                control measures, especially source control (masking),\121\ remain
                critical to safeguarding patients, residents, clients, PACE program
                participants, and staff.
                ---------------------------------------------------------------------------
                 \120\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html.
                 \121\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Accessed 10/15/2021.
                ---------------------------------------------------------------------------
                F. Stakeholder Response to Vaccines
                 There has been growing national interest in COVID-19 vaccination
                requirements among health care workers, including requests from various
                national health care stakeholders. In a joint statement released on
                July 26, 2021, more than 50 health care professional societies and
                organizations called for all health care employers and facilities to
                require that all their staff be vaccinated against COVID-19. Included
                as signatories to this statement were organizations representing
                millions of workers throughout the U.S. health care industry, including
                those representing doctors, nurses, pharmacists, physician assistants,
                public health workers, and epidemiologists as well as long term care,
                home care, and hospice workers.\122\
                ---------------------------------------------------------------------------
                 \122\ https://www.hematology.org/newsroom/press-releases/2021/joint-statement-in-support-of-covid-19-vaccine-mandates-for-all-workers-in-health.
                ---------------------------------------------------------------------------
                 In addition, a large nonprofit, nonpartisan organization focused on
                empowering Americans over the age of 50 recently called on all LTC
                facilities to require vaccinations for staff and residents.\123\ A non-
                profit organization dedicated to advancing dignity in aging issued a
                statement in support of COVID-19 vaccine mandates for staff and
                residents of long-term care facilities.\124\ In a policy statement
                dated July 21, 2021, a large long term care association, ``strongly
                urges all residents and staff in long-term care to get vaccinated'' and
                ``supports requiring vaccines for current and new staff in long-term
                care and other healthcare settings. COVID-19 vaccination should be a
                condition of employment for all healthcare workers, including
                employees, contract staff and others, with appropriate exemptions for
                those with medical reasons or as specified by federal or state law.''
                \125\ The statement further notes that ``COVID-19 vaccines are safe . .
                . effective for preventing infection, and especially severe illness and
                death [and] reduce the risk of spreading the virus.'' \126\ Moreover,
                the
                [[Page 61566]]
                statement observes that ``the COVID crisis exacerbated long-standing
                workforce challenges, and some in the sector fear that a vaccine
                mandate could lead to worker resignations. But providers that have
                required staff vaccination have reported high vaccine accepted by
                previously hesitant care professionals, and many providers report that
                when staff vaccination rates are high, they become providers of choice
                in their communities.'' \127\ A non-profit federation of affiliated
                State health organizations, representing more than 14,000 non-profit
                and for-profit nursing homes, assisted living communities, and
                facilities for individuals with disabilities expressed support for all
                health care ``strongly urges the vaccination of all health care
                personnel'' to ``protect all residents, staff and others in our
                communities from the known and substantial risks of COVID-19.'' They
                also assert that ``COVID-19 vaccines protect health care personnel when
                working both in health care facilities and in the community,'' and
                ``provide strong protection against workers unintentionally carrying
                the disease to work and spreading it to patients and peers.'' \128\
                ---------------------------------------------------------------------------
                 \123\ https://press.aarp.org/2021-8-12-New-AARP-Analysis-Shows-Nursing-Homes-Vaccination-Rates-Still-Well-Short-of-Benchmark-as-COVID-Cases-Trend-Upwards.
                 \124\ https://justiceinaging.org/justice-in-aging-supports-mandatory-covid-vaccinations-in-long-term-care-facilities/, accessed
                10/6/21, 1:02 p.m. EDT.
                 \125\ https://leadingage.org/sites/default/files/LeadingAge%20Statement%20on%20Vaccine%20Mandates%20for%20Healthcare%20Workers.pdf.
                 \126\ Ibid.
                 \127\ Ibid.
                 \128\ https://www.ahcancal.org/News-and-Communications/Press-Releases/Pages/AHCANCAL-Issues-Policy-Statement-Regarding-COVID-19-Vaccinations-of-Long-Term-Care-Personnel.aspx. Accessed 10/16/2021.
                ---------------------------------------------------------------------------
                 Numerous health systems and individual health care employers across
                the country have implemented vaccine mandates independent of this rule.
                For example, a health care system that is the largest private employer
                in Delaware with more than 14,000 employees, a health care system and
                academic medical center with over 26,000 employees in Texas, and an
                integrated health system in North Carolina with more than 35,000
                employees, to name a few, have all preceded this rule with their own
                vaccination requirements, achieving rates of at least 97 percent
                vaccination among their staff.129 130 131 132 These
                organizations are already realizing the effectiveness of strong
                vaccination policies. Despite the successes of these organizations in
                increasing levels of staff vaccination, there remains an inconsistent
                patchwork of requirements and laws that is only effective at local
                levels and has not successfully raised staff vaccination rates
                nationwide. Patients, residents, clients, PACE program participants,
                and staff alike are not adequately protected from COVID-19.
                ---------------------------------------------------------------------------
                 \129\ https://news.christianacare.org/2021/09/safe-care-safe-workplace-we-are-vaccinated/. Accessed 10/15/2021.
                 \130\ https://www.delawareonline.com/story/news/health/2021/09/27/christianacare-fires-employees-not-complying-vaccine-mandate/5887784001/. Accessed 10/15/2021.
                 \131\ https://www.houstonmethodist.org/leading-medicine-blog/articles/2021/jun/houston-methodist-requires-covid-19-vaccine-for-credentialed-doctors/. Accessed 10/15/202021.
                 \132\ https://www.novanthealth.org/home/about-us/newsroom/press-releases/newsid33987/2576/novant-health-update-on-mandatory-covid-19-vaccination-program-for-employees.aspx. Accessed 10/15/2021.
                ---------------------------------------------------------------------------
                 In September 2021, Jeffrey Zients, the White House Coronavirus
                Response Coordinator, noted that ``vaccination requirements work . . .
                and are the best path out of the pandemic.'' He further noted that
                vaccination requirements are not only key to the nation's path out of
                the pandemic, but also accelerate our economic recovery, keeping
                workplaces safer, and helping to curb the spread of the virus in
                communities, and boost job growth, the labor market, and the nation's
                overall economy.
                G. Populations at Higher Risk for Severe COVID-19 Outcomes
                 COVID-19 can affect anyone, with symptoms ranging from mild
                (infections not requiring hospitalization) to very severe (requiring
                intensive care in a hospital). Nonetheless, studies have shown that
                COVID-19 does not affect all population groups equally.\133\ Age
                remains a strong risk factor for severe COVID-19 outcomes.
                Approximately 54.1 million people aged 65 years or older reside in the
                U.S.; this age group accounts for more than 80 percent of U.S. COVID-19
                related deaths. Residents of LTC facilities make up less than 1 percent
                of the U.S. population but accounted for more than 35 percent of all
                COVID-19 deaths in the first 12 months of the pandemic.\134\
                ---------------------------------------------------------------------------
                 \133\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
                 \134\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
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                 Additionally, adults of any age with certain underlying medical
                conditions are at increased risk for severe illness from COVID-19.
                These include, but are not limited to, cancer, cerebrovascular disease,
                diabetes (Type 1 and Type 2), chronic kidney disease, COPD, heart
                conditions, Down Syndrome, obesity, substance use, smoking status, and
                pregnancy.\135\ The risk of severe COVID-19 also increases as the
                number of underlying medical conditions increases in a particular
                individual.
                ---------------------------------------------------------------------------
                 \135\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/underlying-evidence-table.html.
                ---------------------------------------------------------------------------
                 A confluence of structural and epidemiological factors has also
                contributed to disparate risk for COVID-19 infection, severe illness,
                and death in certain populations. For example, evidence clearly
                indicates that racial and ethnic minority groups, including Black and
                Hispanic or Latino, have disproportionately higher hospitalization
                rates among every age group, including children aged younger than 18
                years.\136\ These same groups are disproportionately affected by long-
                standing inequities in social determinants of health, such as poverty
                and health care access, that increase risk of severe illness and death
                from COVID-19.\137\ People with intellectual disabilities are more
                likely to have chronic health conditions, live in congregate settings,
                and face more barriers to health care; some studies suggest they are
                also more likely to get COVID-19 and have worse outcomes.\138\ Finally,
                rural communities often have a higher proportion of residents who live
                with comorbidities or disabilities and are aged >=65 years; these risk
                factors, combined with more limited access to health care facilities
                with intensive care capabilities, place rural dwellers at increased
                risk for COVID-19-associated morbidity and mortality.\139\
                ---------------------------------------------------------------------------
                 \136\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-hospitalization.html.
                 \137\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-illness.html.
                 \138\ https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0051.
                 \139\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e3.htm.
                ---------------------------------------------------------------------------
                 In addition, CDC data indicate that vaccination rates are
                disproportionately low among nurses and health care aides in long term
                care settings, particularly in communities that experience social risk
                factors. Further, CDC data indicate that nurses and aides in these
                settings are more likely to be members of racial and ethnic minority
                communities.\140\ This disparity in vaccination coverage may be
                exacerbating existing and emerging disparities related to COVID-19
                cases and impact, placing members of communities who experience social
                risk factors--those in rural areas with geographic and transportation
                barriers to care, those in low income areas who experience persistent
                poverty and inequality, and others--at further increased risk for
                COVID-19-associated morbidity and mortality.\141\ This disparity may
                be, in part, reduced by the potential positive health equity impacts of
                requiring staff vaccination among provider and supplier types subject
                to rulemaking.
                ---------------------------------------------------------------------------
                 \140\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7030a2.htm.
                 \141\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html.
                ---------------------------------------------------------------------------
                [[Page 61567]]
                 CMS believes that the developing data about staff vaccination rates
                and rates of COVID-19 cases, and the urgent need to address COVID-
                related staffing shortages that are disrupting patient access to care,
                provides strong justification as to the need to issue this IFC
                requiring staff vaccination for most provider and supplier types over
                which we have authority.
                H. CMS Authority To Require Staff Vaccinations
                 CMS has broad statutory authority to establish health and safety
                regulations, which includes authority to establish vaccination
                requirements. Section 1102 of the Act grants the Secretary of Health
                and Human Services authority to make and publish such rules and
                regulations, not inconsistent with the Act, as may be necessary to the
                efficient administration of the functions with which the Secretary is
                charged under the Act. Section 1871 of the Act grants the Secretary of
                Health and Human Services authority to prescribe regulations as may be
                necessary to carry out the administration of the Medicare program. The
                statutory authorities to establish health and safety requirements for
                COVID-19 vaccination for each provider and supplier included in this
                IFC are listed in Table 1 and discussed in sections II.C. through II.F.
                of this IFC.
                [GRAPHIC] [TIFF OMITTED] TR05NO21.022
                 Section 1863 of the Act provides that ``[i]n carrying out his
                functions, relating to determination of conditions of participation by
                providers . . . the Secretary shall consult with appropriate State
                agencies and recognized national listing or accrediting bodies[.]'' For
                the reasons discussed in greater detail throughout sections I. through
                III. this IFC, the COVID-19 pandemic presents a serious and continuing
                threat to the health and to the lives of staff of health care
                facilities and of consumers of these providers' and suppliers'
                services. This threat has grown to be particularly severe since the
                emergence of the Delta variant. Any delay in the implementation of this
                rule would result in additional deaths and serious illnesses among
                health care staff and consumers, further exacerbating the newly-
                arising, and ongoing, strain on the capacity of health care facilities
                to serve the public. For these reasons, in carrying out the agency's
                functions relating to determination of conditions of participation,
                conditions for coverage, and requirements, we intend to engage in
                consultations with appropriate State agencies and listing or
                accrediting bodies following the issuance of this rule, and toward that
                end we invite these entities to submit comments on this IFC. Given the
                urgent need to issue this rule, however, we do not believe that there
                exists an entity with which it would be appropriate to engage in these
                consultations in advance of issuing this IFC, nor do we understand the
                statute to impose a temporal requirement to do so in advance of the
                issuance of this rule.
                 We have not previously required any vaccinations, but we recognize
                that many health care workers already comply with employer or State
                government vaccination requirements (for example, influenza, and
                hepatitis B virus (HBV)) and invasive employer or State government-
                required screening procedures (such as tuberculosis screening).
                Further, most of these
                [[Page 61568]]
                individuals met State and local vaccination requirements in order to
                attend school to complete the necessary education to qualify for health
                care positions. In addition to these longstanding vaccination
                requirements, many now require vaccination for COVID-19 as well.
                However, studies on annual seasonal influenza vaccine uptake
                consistently show that half of health care workers may resist seasonal
                influenza vaccination nationwide.\142\
                ---------------------------------------------------------------------------
                 \142\ Field R.I. (2009). Mandatory vaccination of health care
                workers: whose rights should come first? P & T: a peer-reviewed
                journal for formulary management, 34(11), 615-618.
                ---------------------------------------------------------------------------
                 Other ongoing CMS staff vaccination programs include hospital
                quality improvement contractors that provide educational resources to
                help hospitals and staff overcome vaccine hesitancy, coordinate with
                State health departments to support vaccine uptake (for COVID-19 and
                flu), and monitor staff vaccination rates for additional action. ESRD
                networks also provide education on patient influenza and pneumococcal
                vaccinations as a part of their work and also recently (in 2020) added
                a goal of 85 percent of patients vaccinated for flu while also
                encouraging vaccinations for staff within ESRD facilities. While we
                have not, until now, required any health care staff vaccinations, we
                have established, maintained, and regularly updated extensive health
                and safety requirements (CfCs, CoPs, requirements, etc.) for Medicare-
                and Medicaid-certified providers and suppliers. These requirements
                focus a great deal on infection prevention and control standards, often
                incorporating guidelines as recommended by CDC and other expert groups,
                as CMS's highest duty is to protect the health and safety of patients,
                clients, residents, and PACE program participants in all applicable
                settings.
                 The Medicare statute's various provisions authorizing the Secretary
                to impose requirements necessary in the interest of the health and
                safety of beneficiaries encompass authority to require that staff
                working in and for Medicare-certified providers and suppliers be
                vaccinated against specific diseases. In addition, parallel Medicaid
                statutes provide authority to establish requirements to protect
                beneficiary health and safety, as reflected in Table 1. We acknowledge
                that we have not previously imposed such requirements, but, as
                discussed throughout section I. of this rule, this is a unique pandemic
                scenario with unique access to effective vaccines. In addition, for
                many infectious diseases, it is not necessary for CMS to impose such
                requirements because other entities, including employers, states, and
                licensing organizations, already impose sufficient standards for those
                specific diseases. We believe that, given the fast-moving nature of the
                COVID-19 pandemic and its ongoing threat to the health and safety of
                individuals receiving health care services in Medicare- and Medicaid-
                certified providers and suppliers, our intervention is warranted. We
                understand that some states and localities have established laws that
                would seem to prevent Medicare- and Medicaid-certified providers and
                suppliers from complying with the requirements of this IFC. We intend,
                consistent with the Supremacy Clause of the United States Constitution,
                that this nationwide regulation preempts inconsistent State and local
                laws as applied to Medicare- and Medicaid-certified providers and
                suppliers. CDC estimates that 45.4 percent of U.S. adults are at
                increased risk for complications from coronavirus disease because of
                cardiovascular disease, diabetes, respiratory disease, hypertension, or
                cancer. Rates increased by age, from 19.8 percent for persons 18-29
                years of age to 80.7 percent for persons >80 years of age, and varied
                by State, race/ethnicity, health insurance status, and employment.\143\
                We expect that individuals seeking health care services are more likely
                to fall into the high-risk category. While we do not have provider- or
                supplier-specific estimates, we would anticipate the percentage of
                high-risk individuals in health care settings is much higher than the
                general population. Health care consumers seeking services from the
                provider and suppliers included in this rule are often at significantly
                higher risk of severe disease and death than their paid care
                givers.\144\ As discussed in section I.F. of this IFC, COVID-19 has
                disproportionally affected minority and underserved populations, who
                will receive safer care and better outcomes through this
                requirement.\145\ Families, unpaid caregivers, and communities will
                also experience overall benefit.146 147 Staff will directly
                benefit from the protective effects of COVID-19 vaccination, but the
                primary reason that we are issuing this IFC requiring health care
                workers be vaccinated against COVID-19 is for the protection of
                residents, clients, patients, and PACE program participants.
                ---------------------------------------------------------------------------
                 \143\ https://wwwnc.cdc.gov/eid/article/26/8/20-0679_article.
                 \144\ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.
                 \145\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-impact.html.
                 \146\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
                 \147\ https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11509:cdc%20guidance%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21.
                ---------------------------------------------------------------------------
                I. Vaccination Requirements and Employee Protections
                 This IFC requires most Medicare- and Medicaid-certified providers
                and suppliers to ensure that their staff are fully vaccinated for
                COVID-19. The U.S. Equal Employment Opportunity Commission (EEOC)
                enforces workplace anti-discrimination laws and has established that
                employers can mandate COVID-19 vaccination for all employees that
                physically enter their facility.\148\ We are expanding upon that to
                include all of the staff described in section II.A.1. of this IFC, for
                the providers and suppliers addressed by this IFC, not just those staff
                who perform their duties within a health care facility, as many health
                care staff routinely care for patients and clients outside of such
                facilities, such as home health, home infusion therapy, hospice, and
                therapy staff. In addition, there may be other times that staff
                encounter fellow employees, such as in an administrative office or at
                an off-site staff meeting, who will themselves enter a health care
                facility or site of care for their job responsibilities. Thus, we
                believe it is necessary to require vaccination for all staff that
                interact with other staff, patients, residents, clients, or PACE
                program participants in any location, beyond those that physically
                enter facilities or other sites of patient care.
                ---------------------------------------------------------------------------
                 \148\ What You Should Know About COVID-19 and the ADA, the
                Rehabilitation Act, and Other EEO Laws. U.S. Equal Opportunity
                Commission. Accessed at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
                Accessed on October 16, 2021, 2:20 p.m. EDT. Updated October 13,
                2021. Section K. Vaccinations.
                ---------------------------------------------------------------------------
                 In implementing the COVID-19 vaccination policies and procedures
                required by this IFC, however, employers must comply with applicable
                Federal anti-discrimination laws and civil rights protections.
                Applicable laws include: (1) The Americans with Disabilities Act (ADA);
                (2) Section 504 of the Rehabilitation Act (RA); (3) Title VII of the
                Civil Rights Act of 1964; (4) the Pregnancy Discrimination Act; and (5)
                the Genetic Information Nondiscrimination Act.\149\ In addition, other
                Federal laws may provide employees with additional protections.
                ---------------------------------------------------------------------------
                 \149\ Genetic Information Nondiscrimination Act of 2008. Public
                Law 110-233.
                ---------------------------------------------------------------------------
                 These Federal laws continue to apply during the PHE and, in some
                instances, require employers to offer
                [[Page 61569]]
                accommodations for some individual staff members in some circumstances.
                These laws do not interfere with or prevent employers from following
                the guidelines and suggestions made by CDC or public health authorities
                about steps employers should take to promote public health and safety
                in light of COVID-19, to the extent such guidelines and suggestions are
                consistent with the requirements set forth in this regulation. In other
                words, employers following CDC guidelines and the new requirements in
                this IFC may also be required to provide appropriate accommodations, to
                the extent required by Federal law, for employees who request and
                receive exemption from vaccination because of a disability, medical
                condition, or sincerely held religious belief, practice, or observance.
                 Vaccination against COVID-19 is a critical protective action for
                all individuals, especially health care workers, because the SARS-Cov-2
                virus poses direct threats to patients, clients, residents, PACE
                program participants, and staff. COVID-19 disease at this time is
                resulting in much higher morbidity and mortality than seasonal
                flu.150 151 152 These individual vaccinations provide
                protections to the health care system as a whole, protecting capacity
                and operations during disease outbreaks.
                ---------------------------------------------------------------------------
                 \150\ Comparison of the characteristics, morbidity, and
                mortality of COVID-19 and seasonal influenza: a nationwide,
                population-based retrospective cohort study, The Lancet, Published
                Online December 17, 2020 https://doi.org/10.1016/ S2213-
                2600(20)30527-0.
                 \151\ Comparative evaluation of clinical manifestations and risk
                of death in patients admitted to hospital with covid-19 and seasonal
                influenza: cohort study, BMJ 2020;371:m4677.
                 \152\ Klompas, M, Pearson, M, and Morris, C. The Case for
                Mandating COVID-19 Vaccines for Health Care Workers. Annuals of
                Internal Medicine. Annals.org. Accessed at https://www.acpjournals.org/doi/10.7326/M21-2366. Accessed on August 30,
                2021. Published on July 13, 2021.
                ---------------------------------------------------------------------------
                 We also recognize ethical reasons to issue these vaccination
                requirements. All health care workers have a general ethical duty to
                protect those they encounter in their professional capacity.\153\
                Patient safety is a central tenet of the ethical codes and practice
                standards published by health care professional associations, licensure
                and certification bodies, and specialized industry groups. Health care
                workers also have a special ethical and professional responsibility to
                protect and prioritize the health and well-being of those they are
                caring for, as well as not exposing them to threats that can be
                avoided. This holds true not only for health care professionals, but
                also for all who provide health care services or choose to work in
                those settings. The ethical duty of receiving vaccinations is not new,
                as staff have long been required by employers to be vaccinated against
                certain diseases, such as influenza, hepatitis B, and other infectious
                diseases.
                ---------------------------------------------------------------------------
                 \153\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
                for Health Care Workers. Annuals of Internal Medicine. Annals.org.
                Accessed at https://www.acpjournals.org/doi/10.7326/M21-3150.
                Accessed on August 30, 2021. Article includes the ``Joint Statement
                in Support of COVID-19 Vaccine Mandates for All Workers in Health
                and Long-Term Care'' that is signed by 80 organizations.
                ---------------------------------------------------------------------------
                 We are aware of concerns about health care workers choosing to
                leave their jobs rather than be vaccinated. While we understand that
                there might be a certain number of health care workers who choose to do
                so, there is insufficient evidence to quantify and compare adverse
                impacts on patient and resident care associated with temporary staffing
                losses due to mandates and absences due to quarantine for known COVID-
                19 exposures and illness. We encourage providers and suppliers, where
                possible, to consider on-site vaccination programs, which can
                significantly reduce barriers that health care staff may face in
                getting vaccinated, including transportation barriers, need to take
                time off of work, and scheduling. However, vaccine declination may
                continue to occur, albeit at lower rates, due to hesitancy among
                particular communities, and the Assistant Secretary for Planning and
                Evaluation (ASPE) indicates that vaccination promotion and outreach
                efforts focused on groups and communities who experience social risk
                factors could help address inequities.\154\
                ---------------------------------------------------------------------------
                 \154\ Kolbe A. Disparities in COVID-19 vaccination rates across
                racial and ethnic minority groups in the United States. Washington,
                DC: US Department of Health and Human Services, Office of the
                Assistant Secretary for Planning and Evaluation; 2021. https://aspe.hhs.gov/system/files/pdf/265511/vaccination-disparities-brief.pdf.
                ---------------------------------------------------------------------------
                 Despite these hesitations, many COVID-19 vaccination mandates have
                already been successfully initiated in a variety of health care
                settings, systems, and states. In general, workers across the economy
                are responding to mandates by getting vaccinated.\155\ A large hospital
                system in Texas instituted a vaccine mandate and 99.5 percent of its
                staff received the vaccine. Further, only a few of their staff resigned
                rather than receive the vaccine.\156\ A Detroit-based health system
                also instituted a vaccine mandate, and reported that 98 percent of the
                system's 33,000 workers were fully or partially vaccinated or in the
                process of obtaining a religious or medical exemption when the
                requirement went into effect, with exemptions comprising less than 1
                percent of staffers.\157\ In addition, a LTC parent corporation
                established a COVID-19 vaccine mandate for its more than 250 LTC
                facilities, leading to more than 95 percent of their workers being
                vaccinated. Again, they noted that very few workers quit their jobs
                rather than be vaccinated.\158\ New York enacted a State-wide health
                care worker COVID-19 vaccine mandate and recorded a jump in vaccine
                compliance in the final days before the requirements took effect on
                October 1, 2021.\159\
                ---------------------------------------------------------------------------
                 \155\ https://theconversation.com/half-of-unvaccinated-workers-say-theyd-rather-quit-than-get-a-shot-but-real-world-data-suggest-few-are-following-through-168447.
                 \156\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
                for Health Care Workers. Annuals of Internal Medicine. Annuals.org.
                Accessed https://www.acpjournals.org/doi/10.7326/M21-3150. Accessed
                on August 30, 2021. Article includes the ``Joint Statement in
                Support of COVID-19 Vaccine Mandates for All Workers in Health and
                Long-Term Care'' that is signed by 88 organizations.
                 \157\ https://www.bridgemi.com/michigan-health-watch/despite-protests-98-henry-ford-hospital-workers-get-covid-vaccinations
                accessed 09/15/2021 at 2:24 p.m. EDT.
                 \158\ Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination
                for Health Care Workers. Annuals of Internal Medicine. Annals.org.
                Accessed at https://www.acpjournals.org/doi/10.7326/M21-3150.
                Accessed on August 30, 2021. Article includes the ``Joint Statement
                in Support of COVID-19 Vaccine Mandates for All Workers in Health
                and Long-Term Care'' that is signed by 88 organizations.
                 \159\ https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html.
                ---------------------------------------------------------------------------
                 We believe that the COVID-19 vaccine requirements in this IFC will
                result in nearly all health care workers being vaccinated, thereby
                benefiting all individuals in health care settings. This will greatly
                contribute to a reduction in the spread of and resulting morbidity and
                mortality from the disease, positive steps towards health equity, and
                an improvement in the numbers of health care staff who are healthy and
                able to perform their professional responsibilities. For individual
                staff members that have legally permitted justifications for exemption,
                the providers and suppliers covered by this IFC can address those
                individually.
                II. Provisions of the Interim Final Rule With Comment Period
                 Through this IFC, we are requiring that the following Medicare- and
                Medicaid-certified providers and suppliers, listed here in order of
                their appearance in 42 CFR, ensure that all applicable staff are
                vaccinated for COVID-19:
                 Ambulatory Surgical Centers (ASCs)
                 Hospices
                 Psychiatric residential treatment facilities (PRTFs)
                 Programs of All-Inclusive Care for the Elderly (PACE)
                [[Page 61570]]
                 Hospitals (acute care hospitals, psychiatric hospitals, long
                term care hospitals, children's hospitals, hospital swing beds,
                transplant centers, cancer hospitals, and rehabilitation hospitals)
                 Long Term Care (LTC) Facilities, including SNFs and NFs,
                generally referred to as nursing homes
                 Intermediate Care Facilities for Individuals with Intellectual
                Disabilities (ICFs-IID)
                 Home Health Agencies (HHAs)
                 Comprehensive Outpatient Rehabilitation Facilities (CORFs)
                 Critical Access Hospitals (CAHs)
                 Clinics, rehabilitation agencies, and public health agencies
                as providers of outpatient physical therapy and speech-language
                pathology services
                 Community Mental Health Centers (CMHCs)
                 Home Infusion Therapy (HIT) suppliers
                 Rural Health Clinics (RHCs)/Federally Qualified Health Centers
                (FQHCs)
                 End-Stage Renal Disease (ESRD) Facilities
                 For discussion purposes, we have grouped these providers and
                suppliers into four categories below: (1) Residential congregate care
                facilities; (2) acute care settings; (3) outpatient clinical care and
                services; and (4) home-based care. We note that the appropriate term
                for the individual receiving care and/or services differs depending
                upon the provider or supplier. For example, for hospitals and CAHs, the
                appropriate term is patient, but for ICFs-IID, it is client. Further,
                LTC facilities have residents and PACE Programs have participants. The
                appropriate term is used when discussing each individual provider or
                supplier, but when we are discussing all or multiple providers and
                suppliers we will use the general term ``patient.'' Similarly, despite
                the different terms used for specific provider and supplier entities
                (such as campus, center, clinic, facility, organization, or program),
                when we are discussing all or multiple providers and suppliers, we will
                use the general term ``facility.''
                A. Provisions of the Interim Final Rule With Comment Period
                 In this IFC, we are issuing a common set of provisions for each
                applicable provider and supplier. As there are no substantive
                regulatory differences across settings, we discuss the provisions
                broadly in this section of the rule, along with their rationales. In
                subsequent sections of the rule we discuss any unique considerations
                for each setting.
                1. Staff Subject to COVID-19 Vaccination Requirements
                 The provisions of this IFC require applicable providers and
                suppliers to develop and implement policies and procedures under which
                all staff are vaccinated for COVID-19. Each facility's COVID-19
                vaccination policies and procedures must apply to the following
                facility staff, regardless of clinical responsibility or patient
                contact and including all current staff as well as any new staff, who
                provide any care, treatment, or other services for the facility and/or
                its patients: Facility employees; licensed practitioners; students,
                trainees, and volunteers; and individuals who provide care, treatment,
                or other services for the facility and/or its patients, under contract
                or other arrangement. These requirements are not limited to those staff
                who perform their duties within a formal clinical setting, as many
                health care staff routinely care for patients and clients outside of
                such facilities, such as home health, home infusion therapy, hospice,
                PACE programs, and therapy staff. Further, there may be staff that
                primarily provide services remotely via telework that occasionally
                encounter fellow staff, such as in an administrative office or at an
                off-site staff meeting, who will themselves enter a health care
                facility or site of care for their job responsibilities. Thus, we
                believe it is necessary to require vaccination for all staff that
                interact with other staff, patients, residents, clients, or PACE
                program participants in any location, beyond those that physically
                enter facilities, clinics, homes, or other sites of care. Individuals
                who provide services 100 percent remotely, such as fully remote
                telehealth or payroll services, are not subject to the vaccination
                requirements of this IFC.
                 In the May 13, 2021 COVID-19 IFC, we included an extensive
                discussion on the subject of ``staff'' in relation to the LTC facility
                staff and to whom the testing, reporting, and education and offering of
                COVID-19 vaccine requirements of that rule might apply. In that
                discussion, we considered LTC facility staff to be those individuals
                who work in the facility on a regular (that is, at least once a week)
                basis. We note that this includes those individuals who may not be
                physically in the LTC facility for a period of time due to illness,
                disability, or scheduled time off, but who are expected to return to
                work. We also note that this description of staff differs from that in
                Sec. 483.80(h), established for the LTC facility COVID-19 testing
                requirements in the September 2, 2020 COVID-19 IFC. As in the May 13,
                2021 COVID-19 IFC, we considered applying the Sec. 483.80(h)
                definition to the staff vaccination requirements in this rule, but
                previous public feedback and our own experience tells us the definition
                in Sec. 483.80(h) was overbroad for these purposes.
                 Stakeholders across settings have reported that there are many
                individuals providing occasional health care services under
                arrangement, and that the requirements may be excessively burdensome
                for facilities to apply the definition at Sec. 483.80(h) because it
                includes many individuals who have very limited, infrequent, or even no
                contact with facility staff and residents. Stakeholders also report
                that applying the staff vaccination requirements to these individuals
                who may only make unscheduled visits to the facility would be extremely
                burdensome. That said, the description in this rule still includes many
                of the individuals included in Sec. 483.80(h). In addition to
                facility-employed staff, many facilities have services provided
                directly, on a regular basis, by individuals under contract or
                arrangement, including hospice and dialysis staff, physical therapists,
                occupational therapists, mental health professionals, social workers,
                and portable x-ray suppliers. Any of these individuals who provide such
                health care services at a facility would be included in ``staff'' for
                whom COVID-19 vaccination is now required as a condition for continued
                provision of those services for the facility and/or its patients.
                 In order to best protect patients, families, caregivers, and staff,
                we are not limiting the vaccination requirements of this IFC to
                individuals who are present in the facility or at the physical site of
                patient care based upon frequency. Regardless of frequency of patient
                contact, the policies and procedures must apply to all staff, including
                those providing services in home or community settings, who directly
                provide any care, treatment, or other services for the facility and/or
                its patients, including employees; licensed practitioners; students,
                trainees, and volunteers; and individuals who provide care, treatment,
                or other services for the facility and/or its patients, under contract
                or other arrangement. This includes administrative staff, facility
                leadership, volunteer or other fiduciary board members, housekeeping
                and food services, and others. We considered excluding individual staff
                members who are present at the site of care less frequently than once
                per week from these vaccination requirements, but were concerned that
                this might lead to
                [[Page 61571]]
                confusion or fragmented care. Therefore, any individual that performs
                their duties at any site of care, or has the potential to have contact
                with anyone at the site of care, including staff or patients, must be
                fully vaccinated to reduce the risks of transmission of SARS-CoV-2 and
                spread of COVID-19.
                 Facilities that employ or contract for services by staff who
                telework full-time (that is, 100 percent of their time is remote from
                sites of patient care, and remote from staff who do work at sites of
                care) should identify and monitor these individuals as a part of
                implementing the policies and procedures of this IFC, documenting and
                tracking overall vaccination status, but those individuals need not be
                subject to the vaccination requirements of this IFC. Note, however,
                that these individuals may be subject to other Federal requirements for
                COVID-19 vaccination.
                 We recognize that many infrequent services and tasks performed in
                or for a health care facility are conducted by ``one off'' vendors,
                volunteers, and professionals. Providers and suppliers are not required
                to ensure the vaccination of individuals who infrequently provide ad
                hoc non-health care services (such as annual elevator inspection), or
                services that are performed exclusively off-site, not at or adjacent to
                any site of patient care (such as accounting services), but they may
                choose to extend COVID-19 vaccination requirements to them if feasible.
                Other individuals who may infrequently enter a facility or site of care
                for specific limited purposes and for a limited amount of time, but do
                not provide services by contract or under arrangement, may include
                delivery and repair personnel.
                 We believe it would be overly burdensome to mandate that each
                provider and supplier ensure COVID-19 vaccination for all individuals
                who enter the facility. However, while facilities are not required to
                ensure vaccination of every individual, they may choose to extend
                COVID-19 vaccination requirements beyond those persons that we consider
                to be staff as defined in this rulemaking. We do not intend to prohibit
                such extensions and encourage facilities to require COVID-19
                vaccination for these individuals as reasonably feasible.
                 When determining whether to require COVID-19 vaccination of an
                individual who does not fall into the categories established by this
                IFC, facilities should consider frequency of presence, services
                provided, and proximity to patients and staff. For example, a plumber
                who makes an emergency repair in an empty restroom or service area and
                correctly wears a mask for the entirety of the visit may not be an
                appropriate candidate for mandatory vaccination. On the other hand, a
                crew working on a construction project whose members use shared
                facilities (restrooms, cafeteria, break rooms) during their breaks
                would be subject to these requirements due to the fact that they are
                using the same common areas used by staff, patients, and visitors.
                Again, we strongly encourage facilities, when the opportunity exists
                and resources allow, to facilitate the vaccination of all individuals
                who provide services infrequently and are not otherwise subject to the
                requirements of this IFC.
                2. Determining When Staff Are Considered ``Fully Vaccinated''
                 In consideration of the different vaccines available for COVID-19,
                we require that providers and suppliers ensure that staff are fully
                vaccinated for COVID-19, which, for purposes of these requirements, is
                defined as being 2 weeks or more since completion of a primary
                vaccination series. This definition of ``fully vaccinated'' is
                consistent with the CDC definition. Additionally, the completion of a
                primary vaccination series for COVID-19 is defined in the requirements
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 We note that the concept of a ``primary series'' is commonly
                understood with respect to vaccinations, particularly among health care
                professionals as well as the providers and suppliers regulated by this
                rule. For purposes of this IFC, and if permitted or recommended by CDC,
                COVID-19 vaccine doses from different manufacturers may be combined to
                meet the requirements for a primary vaccination series.
                 We further note that recommendations for booster doses currently
                vary by vaccine and population, and expect that they will continue to
                vary for the foreseeable future. We also require that providers and
                suppliers must have a process for tracking and securely documenting the
                COVID-19 vaccination status of any staff who have obtained any booster
                doses as recommended by the CDC. Additionally, some staff members may
                have been vaccinated during participation in a clinical trial, or in
                countries other than the U.S. We discuss the applicability of these
                less common vaccination pathways in section I.B. of this IFC.
                 Currently, for two of the three vaccines licensed or authorized for
                use in the U.S., the primary vaccination series consists of a defined
                number of doses administered a certain number of weeks apart;
                therefore, we have made this particular requirement effective in two
                different phases. We discuss these implementation phases further in
                section II.B. of this IFC, but note here that Phase 1, effective 30
                days after publication of this IFC, includes the requirement that staff
                receive the first dose, or only dose as applicable, of a COVID-19
                vaccine, or have requested or been granted an exemption to the
                vaccination requirements of this IFC. Phase 2, effective 60 days after
                publication of this IFC, requires that the primary vaccination series
                has been completed and that staff are fully vaccinated, except for
                those staff have been granted exemptions, or those staff for whom
                COVID-19 vaccination must be temporarily delayed, as recommended by
                CDC, due to clinical precautions and considerations. As discussed in
                section II.B. of this IFC, staff who have completed the primary series
                for the vaccine received by the Phase 2 implementation date are
                considered to have met these requirements, even if they have not yet
                completed the 14-day waiting period required for full vaccination.
                3. Infection Prevention and Control
                 We require through this IFC that all applicable providers and
                suppliers have a process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19. While
                every health care facility should be following recommended infection
                control and prevention measures as recommended by CDC as part of their
                provision of safe health care services, not all of the providers and
                suppliers subject to the requirements of this IFC have specific
                infection control and prevention regulations in place. Specifically,
                there are no infection prevention and control requirements for PRTFs,
                RHCs/FQHCs, and HIT suppliers. Therefore, for PRTFs, RHCs/FQHCs, and
                HIT suppliers, we require that they have a process for ensuring that
                they follow nationally recognized infection prevention and control
                guidelines intended to mitigate the transmission and spread of COVID-
                19. This process must include the implementation of additional
                precautions for all staff who are not fully vaccinated for COVID-19.
                For the providers and suppliers included in this IFC that are already
                subject to meeting specific infection prevention and control
                requirements on
                [[Page 61572]]
                an ongoing basis, we require that they have a process for ensuring the
                implementation of additional precautions, intended to mitigate the
                transmission and spread of COVID-19, for all staff who are not fully
                vaccinated for COVID-19.
                4. Documentation of Staff Vaccinations
                 In order to ensure that providers and suppliers are complying with
                the vaccination requirements of this IFC, we are requiring that they
                track and securely document the vaccination status of each staff
                member, including those for whom there is a temporary delay in
                vaccination, such as recent receipt of monoclonal antibodies or
                convalescent plasma. Vaccine exemption requests and outcomes must also
                be documented, discussed further in section II.A.5. of this IFC. This
                documentation will be an ongoing process as new staff are onboarded.
                 While provider and supplier staff may not have personal medical
                records on file with their employer, all staff COVID-19 vaccines must
                be appropriately documented by the provider or supplier. Examples of
                appropriate places for vaccine documentation include a facilities
                immunization record, health information files, or other relevant
                documents. All medical records, including vaccine documentation, must
                be kept confidential and stored separately from an employer's personnel
                files, pursuant to ADA and the Rehabilitation Act.
                 Examples of acceptable forms of proof of vaccination include:
                 CDC COVID-19 vaccination record card (or a legible photo
                of the card),
                 Documentation of vaccination from a health care provider
                or electronic health record, or
                 State immunization information system record.
                 If vaccinated outside of the U.S., a reasonable equivalent of any
                of the previous examples would suffice.
                 Providers and suppliers have the flexibility to use the appropriate
                tracking tools of their choice. For those who would like to use it, CDC
                provides a staff vaccination tracking tool that is available on the
                NHSN website (https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html). This is a generic Excel-based tool available for free to
                anyone, not just NHSN participants, that facilities can use to track
                COVID-19 vaccinations for staff members.
                5. Vaccine Exemptions
                 While nothing in this IFC precludes an employer from requiring
                employees to be fully vaccinated, we recognize that there are some
                individuals who might be eligible for exemptions from the COVID-19
                vaccination requirements in this IFC under existing Federal law.
                Accordingly, we require that providers and suppliers included in this
                IFC establish and implement a process by which staff may request an
                exemption from COVID-19 vaccination requirements based on an applicable
                Federal law. Certain allergies, recognized medical conditions, or
                religious beliefs, observances, or practices, may provide grounds for
                exemption. With regard to recognized clinical contraindications to
                receiving a COVID-19 vaccine, facilities should refer to the CDC
                informational document, Summary Document for Interim Clinical
                Considerations for Use of COVID-19 Vaccines Currently Authorized in the
                United States, accessed at https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf.
                 As described in section I.I. of this IFC, there are Federal laws,
                including the ADA, section 504 of the Rehabilitation Act, section 1557
                of the ACA, and Title VII of the Civil Rights Act, that prohibit
                discrimination based on race, color, national origin, religion,
                disability and/or sex, including pregnancy. We recognize that, in some
                circumstances, employers may be required by law to offer accommodations
                for some individual staff members. Accommodations can be addressed in
                the provider or supplier's policies and procedures.
                 Applicable staff of the providers and suppliers included in this
                IFC must be able to request an exemption from these COVID-19
                vaccination requirements based on an applicable Federal law, such as
                the Americans with Disabilities Act (ADA) and Title VII of the Civil
                Rights Act of 1964. Providers and suppliers must have a process for
                collecting and evaluating such requests, including the tracking and
                secure documentation of information provided by those staff who have
                requested exemption, the facility's decision on the request, and any
                accommodations that are provided.
                 Requests for exemptions based on an applicable Federal law must be
                documented and evaluated in accordance with applicable Federal law and
                each facility's policies and procedures. As is relevant here, this IFC
                preempts the applicability of any State or local law providing for
                exemptions to the extent such law provides broader exemptions than
                provided for by Federal law and are inconsistent with this IFC.
                 For staff members who request a medical exemption from vaccination,
                all documentation confirming recognized clinical contraindications to
                COVID-19 vaccines, and which supports the staff member's request, must
                be signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws. Such documentation must contain all
                information specifying which of the authorized COVID-19 vaccines are
                clinically contraindicated for the staff member to receive and the
                recognized clinical reasons for the contraindications; and a statement
                by the authenticating practitioner recommending that the staff member
                be exempted from the facility's COVID-19 vaccination requirements based
                on the recognized clinical contraindications.
                 Under Federal law, including the ADA and Title VII of the Civil
                Rights Act of 1964 as noted previously, workers who cannot be
                vaccinated or tested because of an ADA disability, medical condition,
                or sincerely held religious beliefs, practice, or observance may in
                some circumstances be granted an exemption from their employer. In
                granting such exemptions or accommodations, employers must ensure that
                they minimize the risk of transmission of COVID-19 to at-risk
                individuals, in keeping with their obligation to protect the health and
                safety of patients. Employers must also follow Federal laws protecting
                employees from retaliation for requesting an exemption on account of
                religious belief or disability status. For more information about these
                situations, employers can consult the Equal Employment Opportunity
                Commission's website at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
                 We also direct providers and suppliers to the Equal Employment
                Opportunity Commission (EEOC) Compliance Manual on Religious
                Discrimination \160\ for information on evaluating and responding to
                such requests. While employers have the flexibility to establish their
                own processes and procedures, including forms, we point to The Safer
                Federal Workforce Task Force's ``request for a religious exception to
                the COVID-19 vaccination requirement'' template as an example. This
                template can be viewed at https://
                [[Page 61573]]
                www.saferfederalworkforce.gov/downloads/RELIGIOUS%20REQUEST%20FORM%20-
                %2020211004%20-%20MH508.pdf.
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                 \160\ https://www.eeoc.gov/laws/guidance/section-12-religious-discrimination.
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                6. Planning
                 Despite the near-universal applicability of the requirements
                described in sections II.A.1. through 5 of this IFC, we recognize that
                the course of the COVID-19 pandemic remains unpredictable. Due to
                likely unforeseen circumstances, we require that providers and
                suppliers make contingency plans in consideration of staff that are not
                fully vaccinated to ensure that they will soon be vaccinated and will
                not provide care, treatment, or other services for the provider or its
                patients until such time as such staff have completed the primary
                vaccination series for COVID-19 and are considered fully vaccinated,
                or, at a minimum, have received a single-dose COVID-19 vaccine, or the
                first dose of the primary vaccination series for a multi-dose COVID-19
                vaccine. This planning should also address the safe provision of
                services by individuals who have requested an exemption from
                vaccination while their request is being considered and by those staff
                for whom COVID-19 vaccination must be temporarily delayed, as
                recommended by the CDC, due to clinical precautions and considerations.
                 While the nature of this rulemaking suggests the potential that
                virtually all health care staff in the U.S. will be vaccinated for
                COVD-19 within a matter of months, local outbreaks, new viral
                variations, changes in disease manifestation, or other factors
                necessitate contingency planning. Contingency planning may extend
                beyond the specific requirements of this rule to address topics such as
                staffing agencies that can supply vaccinated staff if some of the
                facility's staff are unable to work. Contingency plans might also
                address special precautions to be taken when, for example, there is a
                regional or local emergency declaration, such as for a hurricane or
                flooding, which necessitates the temporary utilization of unvaccinated
                staff, in order to assure the safety of patients. For example,
                expedient evacuation of a flooding LTC facility may require assistance
                from local community members of unknown vaccination status. Facilities
                may already have contingency plans that meet the requirements of this
                IFC in their existing Emergency Preparedness policies and procedures.
                B. Implementation Dates
                 Due to the urgent nature of the vaccination requirements
                established in this IFC, we have not issued a proposed rule, as
                discussed in section III. of this IFC. While some IFCs are effective
                immediately upon publication, we understand that instantaneous
                compliance, or compliance within days, with these regulations is not
                possible. Vaccination requires time, especially those vaccines
                delivered in a series, and facilities may wish to coordinate scheduling
                of staff vaccination appointments in a staggered manner so that
                appropriate coverage is maintained. The policies and procedures
                required by the IFC will also take time for facilities to develop.
                However, in order to provide protection to residents, patients,
                clients, and PACE program participants (as applicable), we believe it
                is necessary to begin staff vaccinations as quickly as reasonably
                possible.
                 In order to provide protection as soon as possible, we are
                establishing two implementation phases for this IFC. Phase 1, effective
                30 days after publication, includes nearly all provisions of this IFC,
                including the requirements that all staff have received, at a minimum,
                the first dose of the primary series or a single dose COVID-19 vaccine,
                or requested and/or been granted a lawful exemption, prior to staff
                providing any care, treatment, or other services for the facility and/
                or its patients. Phase 1 also includes the requirements for facilities
                to have appropriate policies and procedures developed and implemented,
                and the requirement that all staff must have received a single dose
                COVID-19 vaccine or the initial dose of a primary series by December 6,
                2021.
                 Phase 2, effective 60 days after publication, consists of the
                requirement that all applicable staff are fully vaccinated for COVID-
                19, except for those staff who have been granted exemptions from COVID-
                19 vaccination or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations). Although an individual is not
                considered fully vaccinated until 14 days (2 weeks) after the final
                dose, staff who have received the final dose of a primary vaccination
                series by the Phase 2 effective date are considered to have meet the
                individual vaccination requirements, even if they have not yet
                completed the 14-day waiting period. For example, an individual may
                receive the first dose of the Moderna mRNA COVID-19 Vaccine 2 or 3 days
                prior to the Phase 1 deadline, but must wait at least 28 days before
                receiving the second dose. This second dose could (and must, for
                purposes of this IFC) be administered prior to the Phase 2 effective
                date, but the individual would still be subject to meeting additional
                precautions as described in section II.A.3. of this IFC until 14 days
                had passed. This timing flexibility applies only to the initial
                implementation of this IFC and has no bearing on ongoing compliance.
                This information is also presented in Table 2.
                [[Page 61574]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.023
                 We note that although this IFC is being issued in response to the
                PHE for COVID-19, we expect it to remain relevant for some time beyond
                the end of the formal PHE. Depending on the future nature of the COVID-
                19 pandemic, we may retain these provisions as a permanent requirement
                for facilities, regardless of whether the Secretary continues the
                ongoing PHE declarations. Therefore, this rulemaking's effectiveness is
                not associated with or tied to the PHE declarations, nor is there a
                sunset clause. Pursuant to section 1871(a)(3) of the Act, Medicare
                interim final rules expire 3 years after issuance unless finalized. We
                expect to make a determination based on public comments, incidence,
                disease outcomes, and other factors regarding whether it will be
                necessary to conduct final rulemaking and make this rule permanent.
                C. Enforcement
                 As we do with all new or revised requirements, CMS will issue
                interpretive guidelines, which include survey procedures, following
                publication of this IFC. We will advise and train State surveyors on
                how to assess compliance with the new requirements among providers and
                suppliers. For example, the guidelines will instruct surveyors on how
                to determine if a provider or supplier is compliant with the
                requirements by reviewing the entity's records of staff vaccinations,
                such as a list of all staff and their individual vaccination status or
                qualifying exemption. The guidelines will also instruct surveyors to
                conduct interviews staff to verify their vaccination status.
                Furthermore, the entity's policy and procedures will be reviewed to
                ensure each component of the requirement has been addressed. We will
                also provide guidance on how surveyors should cite providers and
                suppliers when noncompliance is identified. Lastly, providers and
                suppliers that are cited for noncompliance may be subject to
                enforcement remedies imposed by CMS depending on the level of
                noncompliance and the remedies available under Federal law (for
                example, civil money penalties, denial of payment for new admissions,
                or termination of the Medicare/Medicaid provider agreement). CMS will
                closely monitor the status of staff vaccination rates, provider
                compliance, and any other potential risks to patient, resident, client,
                and PACE program participant health and safety.
                [[Page 61575]]
                D. Residential Congregate Care Facilities
                 Individuals residing in congregate care settings such as LTC
                facilities, intermediate care facilities for individuals with
                intellectual disabilities (ICFs-IID), and psychiatric residential
                treatment facilities for individuals under 21 years of age (PRTFs),
                regardless of health or medical conditions, are at greater risk of
                acquiring infections. This higher risk applies to most bacterial and
                viral infections, including SARS-CoV-2. Staff working in these
                facilities often work across facility types (that is, LTC facilities,
                group homes, assisted living facilities, in home and community-based
                services settings, and even different congregate settings within the
                employer's purview), and for different providers, which may contribute
                to virus transmission. Other factors impacting virus transmission in
                these settings might include: Clients or residents who are employed
                outside the congregate living setting; clients or residents who require
                close contact with staff or direct service providers; clients or
                residents who have difficulty understanding information or practicing
                preventive measures; and clients or residents in close contact with
                each other in shared living or working spaces.
                1. Long Term Care Facilities (Skilled Nursing Facilities and Nursing
                Facilities)
                 Long term care (LTC) facilities, a category that includes Medicare
                skilled nursing facilities (SNFs) and Medicaid nursing facilities
                (NFs), also collectively called nursing homes, must meet the
                consolidated Medicare and Medicaid requirements for participation
                (requirements) for LTC facilities (42 CFR part 483, subpart B) that
                were first published in the Federal Register on February 2, 1989 (54 FR
                5316). These regulations have been revised and added to since that
                time, principally as a result of legislation or a need to address
                specific issues. The requirements were comprehensively revised and
                updated in October 2016 (81 FR 68688), including a comprehensive update
                to the requirements for infection prevention and control.
                 CMS establishes requirements for acceptable quality in the
                operation of health care entities. LTC facilities are required to
                comply with the requirements in 42 CFR part 483, subpart B, to receive
                payment under the Medicare or Medicaid programs. In addition to several
                discrete requirements set out under sections 1819 and 1919 of the Act,
                Medicare- and Medicaid-participating LTC facilities ``must meet such
                other requirements relating to the health, safety, and well-being of
                residents or relating to the physical facilities thereof as the
                Secretary may find necessary.'' \161\ More specifically, the infection
                control requirements for LTC facilities are based on sections
                1819(d)(3)(A) (for skilled nursing facilities) and 1919(d)(3)(A) (for
                nursing facilities) of the Act, which both require that a facility
                establish and maintain an infection control program designed to provide
                a safe, sanitary, and comfortable environment in which residents reside
                and to help prevent the development and transmission of disease and
                infection.
                ---------------------------------------------------------------------------
                 \161\ Section 1819(d)(4)(B) of the Act. Section 1919(d)(4)(B) is
                nearly identical, but omitting ``well-being''.
                ---------------------------------------------------------------------------
                 Since the onset of the PHE, we have revised the requirements for
                LTC facilities through three IFCs focused on COVID-19 testing, data
                reporting and vaccine requirements for residents and staff.
                Specifically, we have published the following IFCs:
                 The first IFC, ``Medicare and Medicaid Programs, Basic
                Health Program, and Exchanges; Additional Policy and Regulatory
                Revisions in Response to the COVID-19 Public Health Emergency and Delay
                of Certain Reporting Requirements for the Skilled Nursing Facility
                Quality Reporting Program'' (FR27550) was published on May 8, 2020. The
                May 8, 2020 COVID-19 IFC established requirements for LTC facilities to
                report information related to COVID-19 cases among facility residents
                and staff, we received 299 public comments. About 161, or over one-half
                of those comments, addressed the requirement for COVID-19 reporting for
                LTC facilities set forth at Sec. 483.80(g).
                 The second IFC, ``Medicare and Medicaid Programs, Clinical
                Laboratory Improvement Amendments (CLIA), and Patient Protection and
                Affordable Care Act; Additional Policy and Regulatory Revisions in
                Response to the COVID-19 Public Health Emergency'' (FR54873) was
                published on September 2, 2020. The September 2, 2020 COVID-19 IFC
                strengthened CMS' ability to enforce compliance with LTC facility
                reporting requirements and established a new requirement for LTC
                facilities to test facility residents and staff for COVID-19. We
                received 171 public comments in response to the September 2, 2020
                COVID-19 IFC, of which 113 addressed the requirement for COVID-19
                testing of LTC facility residents and staff set forth at Sec.
                483.80(h).
                 The third IFC, ``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'' (86FR26306) was
                published on May 13, 2021. We received 71 public comments in response
                to the May 13, 2021 COVID-19 IFC, of which most addressed the
                requirements for COVID-19 educating, offering, and reporting of the
                uptake of COVID-19 vaccine for LTC facility residents and staff set
                forth at Sec. Sec. 483.80(d)(3) and 483.80(g)(1). In that rule, we
                also required the educating, offering, and recommended voluntary
                reporting of COVID-19 vaccine uptake in ICFs-IID facility clients and
                staff set forth at Sec. Sec. 483.430, Facility Staffing requirements,
                and 483.460, Health Care Services for Clients.
                 Under Sec. 483.80(d)(3), as established in the May 13, 2021 IFC,
                we require LTC facilities to educate residents and staff on the COVID-
                19 vaccines and also to offer the vaccine, when available, to all
                residents and staff. The May 13, 2021 IFC also required LTC facilities
                to report both resident and staff vaccine uptake and status to CDC's
                National Healthcare Safety Network (NHSN) (Sec. 483.80(d)(3)(vii));
                this has been a requirement since May 21, 2021. The CDC data collected
                under this requirement show that vaccination rates for LTC facility
                staff have stalled, with a 64 percent national average of vaccinated
                staff according to CDC data as of August 28, 2021, while the number of
                new LTC facility resident COVID-19 cases reported per week has risen by
                just over 1455 percent from recorded lows in June 2021 (323 cases in
                the week ending June 27, 2021; 4701 in the week ending August 22,
                2021). There is wide variation among states in staff vaccination rates.
                 With this IFC, we are amending the requirements at Sec. 483.80,
                Infection Control, by revising paragraph (d)(3)(v) by deleting the
                words, ``or a staff member,'' and adding the word, ``or'' before
                ``resident representative,'' so that the provision now reads, ``the
                resident, or resident representative, has the opportunity to accept or
                refuse a COVID-19 vaccine, and change their decision.'' Retaining the
                language permitting staff to refuse vaccination would be inconsistent
                with the goals of this IFC. We are further amending the requirements at
                Sec. 483.80 to add a new paragraph (i), titled ``COVID-19 Vaccination
                of facility staff,'' to specify that facilities must now develop and
                implement policies and procedures to ensure that all staff are fully
                [[Page 61576]]
                vaccinated--that is, staff for whom it has been 2 weeks or more since
                they completed a primary vaccination series for COVID-19, with the
                completion of a primary vaccination series for COVID-19 defined as the
                administration of a single-dose vaccine, or the administration of all
                required doses of a multi-dose vaccine.
                 For this rule, we have also added a new paragraph at Sec.
                483.80(i)(2), which specifies which staff for whom the requirements for
                staff COVID-19 vaccination will not apply: (1) Staff who exclusively
                provide telehealth or telemedicine services outside of the facility
                setting and who do not have any direct contact with residents and other
                staff (for whom the requirements do apply) and (2) staff who provide
                support services for the facility that are performed exclusively
                outside of the facility setting and who do not have any direct contact
                with residents and other staff (for whom the requirements do apply).
                 Additionally, under the requirements of this IFC, we are adding
                Sec. 483.80(i)(3) to now require that a facility's policies and
                procedures for COVID-19 vaccination of staff must include, at a
                minimum, the components specified in section II.A. of this IFC. New
                Sec. Sec. 483.80(i)(3)(i) through (x) specify these required minimum
                components of the facility's policies and procedures.
                2. Intermediate Care Facilities for Individuals With Intellectual
                Disabilities (ICFs-IID)
                 ICFs-IID are residential facilities that provide services for
                people with intellectual disabilities. ICF-IID clients with certain
                underlying medical or psychiatric conditions may be at increased risk
                of serious illness from COVID-19.\162\ On March 2, 2021, CDC issued
                Interim Considerations for Phased Implementation of COVID-19
                Vaccination and Sub Prioritization Among Recommended Populations, which
                notes that increased rates of transmission have been observed in these
                settings, and that jurisdictions may choose to prioritize vaccination
                of persons living in congregate settings based on local, State, tribal,
                or territorial epidemiology. CDC further notes that congregate living
                facilities may choose to vaccinate residents and clients at the same
                time as staff, due to numerous factors, such as convenience or shared
                increased risk of disease.
                ---------------------------------------------------------------------------
                 \162\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html.
                ---------------------------------------------------------------------------
                 Sections 1905(c) and (d) of the Act gave the Secretary authority to
                prescribe regulations for intermediate care facility services in
                facilities for individuals with intellectual disabilities or persons
                with related conditions. The ICFs-IID Conditions of Participation were
                issued on June 3, 1988 (53 FR 20496) and were last updated on May 13,
                2021 (86 FR 20448). There are currently 5,768 Medicare- and/or
                Medicaid-certified ICFs-IID. As of April 2021, 4,661 of the 5,770 are
                small (1 to 8 beds) in size, but there are 1,107 that are larger (14 or
                more beds) facilities. These facilities serve over 64,812 individuals
                with intellectual disabilities and other related conditions. All must
                qualify for Medicaid coverage. While national data about ICFs-IID
                clients is limited, we take an example from Florida where almost one
                quarter of clients (23 percent) require 24-hour nursing services and a
                medical care plan in addition to their services plans.\163\ Data from a
                single State are not nationally representative and thus we are unable
                to generalize, but it is illustrative.
                ---------------------------------------------------------------------------
                 \163\ http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonWebsite2-14.pdf.
                ---------------------------------------------------------------------------
                 Currently, the Conditions of Participation: ``Health Care
                Services'' at Sec. 483.460(a)(4)(i) require that ICFs-IID offer
                clients and staff vaccination against COVID-19 when vaccine supplies
                are available (86 FR 26306). Based on anecdotal reports, this new
                requirement has not significantly increased vaccination among ICFs-IID
                staff. We conclude that additional regulatory action is necessary to
                achieve widespread vaccination among ICFs-IID staff to protect ICFs-IID
                clients.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                483.430(g) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (includes employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                3. Psychiatric Residential Treatment Facilities (PRTFs)
                 PRTFs are non-hospital facilities that provide inpatient
                psychiatric services to Medicaid-eligible individuals under the age of
                21 (also called the ``psych under 21 benefit''). There are 357 PRTFs in
                the U.S. The facilities must meet accreditation standards, the
                requirements in Sec. Sec. 441.151 through 441.182, and the Condition
                of Participation on the use of restraint and seclusion at Sec. 483.350
                through Sec. 483.376.
                 Among the requirements for the psych under 21 benefit are
                certification of need for inpatient care and a plan of care for active
                treatment developed by an interdisciplinary team. The psych under 21
                benefit is significant as a means for Medicaid to cover the cost of
                inpatient behavioral health services. The Federal Medicaid program does
                not reimburse states for the cost of covered services provided to
                beneficiaries in institutions for mental diseases (IMDs) except in
                specific, statutorily-authorized exceptions, including for young people
                who receive this service, and individuals age 65 or older served in an
                IMD. A PRTF provides comprehensive behavioral health treatment to
                children and adolescents (youth) who, due to mental illness, substance
                use disorders, or severe emotional disturbance, need treatment that can
                most effectively be provided in a residential treatment facility. PRTF
                programs are designed to offer a short term, intense, focused
                behavioral health treatment program to promote a successful return of
                the youth to the community.
                 As a congregate living setting, PRTFs are subject to many of the
                same elevated transmission risk factors as LTC facilities and ICFs-IID
                as set forth in section I. of this IFC. Section 1905(h) of the Act
                defines inpatient psychiatric hospital services for individuals under
                21 as any inpatient facility that the Secretary has prescribed in
                regulations that in the case of any individual involve active treatment
                which meets such standards as may be prescribed in regulations by the
                Secretary. Implementing essential infection control practices,
                including vaccination, is a basic infection control treatment standard.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                441.151(c) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (includes employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its clients.
                E. Acute Care Settings
                 Acute care settings are those providers who generally provide
                active care for short-term medical needs. For our discussion purposes
                acute care settings include: Hospitals, critical access hospitals
                (CAHs), and ambulatory surgical centers (ASCs).
                1. Hospitals
                 Hospitals are large health care providers that treat patients with
                acute
                [[Page 61577]]
                care needs including emergency medicine, surgery, labor and delivery,
                cardiac care, oncology, and a wide variety of other services. Hospitals
                also administer general and specialty care that cannot safely be
                provided in other settings, under the supervision of physicians and
                licensed practitioners. They may operate as independent institutions or
                as part of a larger health care system or learning institution.
                 Section 1861(e) of the Act provides that hospitals participating in
                Medicare and Medicaid must meet certain specified requirements, and the
                Secretary may impose additional requirements if they are found
                necessary in the interest of the health and safety of the individuals
                who are furnished services in hospitals. Medicare-participating
                hospitals, which include nearly all hospitals in the U.S., must meet
                the Conditions of Participation (CoPs) at 42 CFR part 482, originally
                issued June 17, 1986. In addition to smaller updates over the years,
                these CoPs were reformed in 2012 (77 FR 29034). Hospital CoPs identify
                infection control and prevention as a basic hospital function and lay
                out specific requirements at 42 CFR 482.42. Infection control within a
                hospital campus is especially important, because hospitals treat
                individuals with infectious diseases (such as COVID-19) and healthy yet
                higher-risk individuals (for example, pregnant and post-partum
                individuals, infants, transplant recipients, etc.) within the same
                facility. Hospitals that provide emergency care must do so in
                accordance with the requirements of the Emergency Medical Treatment and
                Labor Act (EMTALA) of 1986.
                 Hospitals have borne the brunt of caring for patients with acute
                COVID-19 during the PHE. Individuals experiencing respiratory problems,
                cardiac events, kidney failure, and other serious effects of COVID-19
                illness have required in-hospital care in large numbers, to the point
                of occupying or even exceeding most or all critical care or ICU
                capacity in a facility, city, or region. Despite emergency expansion of
                critical care units, these waves of severely ill patients have
                overwhelmed hospitals, health care systems, and the professionals and
                other staff who work in them. This has had the disastrous effect of
                limiting access and increasing risk to both routine and emergency
                hospital care across the U.S.164 165 166 167
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                 \164\ https://www.nytimes.com/live/2021/09/23/world/covid-delta-variant-vaccine#covid-alaska-hospital, accessed 10/18/2021.
                 \165\ https://www.healthline.com/health-news/how-surging-delta-variant-is-leading-to-rationed-care-at-hospitals, accessed 10/18/
                2021.
                 \166\ https://www.aamc.org/news-insights/worst-surge-we-ve-seen-some-hospitals-delta-hot-spots-close-breaking-point, accessed 10/18/
                2021.
                 \167\ https://www.washingtonpost.com/health/2021/08/18/covid-hospitals-delta/, accessed 10/18/2021.
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                 Transplant centers, psychiatric hospitals, and swing beds are
                governed by the infection control CoPs for hospitals, and are thus
                subject to the staff vaccination requirements issued in this IFC. We
                are particularly concerned about transplant center patients, who are
                among the most severely immunocompromised individuals due to anti-
                rejection medications that ensure the function of transplanted organs.
                An additional member of the transplant ecosystem, Organ Procurement
                Organizations (OPOs) coordinate and support donation, recovery, and
                placement of organs. As OPO staff do not provide patient care, and
                typically work in locations removed from health care facilities, we are
                not issuing vaccination requirements for OPOs in this IFC. That said,
                we note that the vaccination policies required in this IFC apply to all
                individuals who provide care, treatment, or other services for the
                hospital and/or its patients, under contract or other arrangement.
                Accordingly, OPO staff members that provide organ transplantation
                services directly to hospital and transplant center patients and
                families must meet the vaccination requirements of this IFC.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 482.42(g)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (including employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                2. Critical Access Hospitals (CAHs)
                 CAHs are rural hospitals that have been designated as critical
                access hospitals by the State, in a State that has established a State
                Medicare Rural Hospital Flexibility Program. These hospitals have 25 or
                fewer acute care inpatient beds (except as permitted for CAHs having
                distinct part units under Sec. 485.647, where the beds in the distinct
                part are excluded from the 25 inpatient-bed count limit specified in
                Sec. 485.620(a)), must be more than 35 miles away from another
                hospital, and provide emergency care services 24 hours a day, 7 days a
                week. On average, acute patients stay in CAHs for less than 96 hours.
                CAHs may be granted approval to provide post-hospital skilled nursing
                care, may offer hospice care under the Medicare hospice benefit, and
                may operate a psychiatric and/or rehabilitation distinct part unit of
                up to 10 beds each. CAHs also administer general and specialty care
                that cannot safely be provided in other settings, under the supervision
                of physicians and licensed practitioners. They may operate as
                independent institutions or as part of a larger health care system.
                Generally, they serve to help ensure access to health-care services in
                rural communities.
                 Section 1820 of the Act sets forth the conditions for certifying a
                facility as a CAH to include meeting such other criteria as the
                Secretary may require. Medicare-certified CAHs must meet the Conditions
                of Participation (CoPs) at 42 CFR part 485 subpart F, originally issued
                May 26, 1993 (58 FR 30630). These CoPs contain specific requirements
                for infection control and prevention at Sec. 485.640. Much like a
                standard hospital, infection control within a CAH is especially
                important, because CAHs treat individuals with infectious diseases
                (such as COVID-19) and healthy yet higher-risk individuals (for
                example, pregnant and post-partum individuals, infants, transplant
                recipients, etc.) within the same facility.
                 While organ transplants are not performed in CAHs, we note that
                organ donors may be CAH patients, and organ donation and recovery may
                occur in CAHs. We note that the vaccination policies required in this
                IFC apply to all individuals who provide care, treatment, or other
                services for the hospital and/or its patients, under contract or other
                arrangement. Accordingly, OPO staff members that provide organ donation
                and transplantation services directly to CAH patients and families must
                meet the vaccination requirements of this IFC in the same manner as
                they meet such requirements for hospitals.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                485.640(f) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (including employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                3. Ambulatory Surgical Centers (ASCs)
                 ASCs are distinct entities that operate exclusively for the purpose
                of providing surgical services to patients not requiring
                hospitalization, and in which the expected duration of services would
                not exceed 24 hours following an
                [[Page 61578]]
                admission. The surgical services performed in ASCs generally are
                scheduled, non-life-threatening procedures that can be safely performed
                in either a hospital setting (inpatient or outpatient) or in an ASC.
                Currently, there are 6,071 Medicare-certified ASCs in the U.S.
                 Section 1833(i)(1)(A) of the Act authorizes the Secretary to
                specify those surgical procedures that can be performed safely in an
                ASC. Section 1832(a)(2)(F)(i) of the Act defines an ASC as a facility
                ``which meets health, safety, and other standards specified by the
                Secretary in regulations . . .''.
                 The ASC Conditions for Coverage (CfCs) at 42 CFR part 416, subpart
                C, are the minimum health and safety standards a center must meet to
                obtain Medicare certification. The ASC CfCs were issued on August 5,
                1982 (47 FR 34082), and the Conditions related to infection control
                were last updated on November 18, 2008 (73 FR 68502, 68813). Section
                416.51, Infection control, requires ASCs to maintain an infection
                control program that seeks to minimize infections and communicable
                diseases. In this IFC we are adding new Sec. 416.51(c) which requires
                ASCs to meet the same COVID-19 vaccination of staff requirements as
                those we are issuing for the other providers and suppliers identified
                in this rule.
                 During the COVID-19 pandemic and PHE, hospitals moved many non-
                elective surgical procedures to ASCs and other outpatient settings.
                Such movement conserves hospital resources for treating severe COVID-
                19, performing more urgent procedures, and caring for patients with
                more critical health needs. Moreover, referring patients in need of
                suitable procedures to ASCs limits the overall number of individuals
                visiting the hospital setting, thereby inhibiting spread of infection.
                ASCs also offer an alternative setting for outpatient surgery for
                individuals reluctant to enter a hospital due to fears of COVID-19
                exposure. Based on these and other factors, the demand for ASC services
                has increased.\168\
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                 \168\ https://www.beckersasc.com/asc-news/5-ways-covid-19-affected-ascs-in-2020.html. Accessed 10/17/2021.
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                 In response to the COVID-19 pandemic, ASCs assumed new roles. CMS's
                Hospital Without Walls initiative permitted hospitals to provide
                inpatient care in ASCs and other temporary sites. ASCs have assisted
                with COVID-19 testing. They provided staff to work in COVID-19 hot
                spots. These efforts illustrate that staff and patients of ASCs
                regularly interact with staff and patients of other health care
                organizations and facilities.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 416.51(c)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (includes employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                F. Outpatient Clinical Care & Services
                 These clinical settings provide necessary, ongoing care for
                individuals who need ongoing therapeutic, and in some cases life-
                sustaining, care. While many of these settings have been able to
                provide some services safely and effectively via telehealth during the
                PHE, many of the services they provide require patients and clients to
                see staff in person.
                1. End-Stage Renal Disease (ESRD) Facilities
                 ESRD facilities provide a set of life-sustaining services to
                individuals without kidney function, including dialysis, medication,
                routine evaluations and monitoring, nutritional counselling, social
                support, and organ transplantation evaluation and referral. Section
                1881(b)(1)(A) of the Act authorizes the Secretary to pay only those
                dialysis facilities ``which meet such requirements as the Secretary
                shall by regulation prescribe for institutional dialysis services and
                supplies . . .'' also known as CfCs. The ESRD facility CfCs at 42 CFR
                part 494 are the minimum health and safety rules that all Medicare- and
                Medicaid-certified dialysis facilities must meet in order to
                participate in the programs. The ESRD CfCs were initially issued in
                1976 and were comprehensively revised in 2008 (73 FR 20370). There are
                currently 7,893 Medicare-certified ESRD facilities in the U.S., serving
                over 500,000 patients.
                 Routine dialysis treatments, typically delivered 3 times per week,
                remove toxins from a patient's blood and are necessary to sustain life.
                Dialysis treatments are most often delivered in the ESRD facility but
                can be performed by the patients themselves at home, or in the
                patient's nursing facility with assistance. ESRD facilities serve
                patients whether they are diagnosed with COVID-19 or not, and people
                receiving dialysis cannot always be adequately distanced from one
                another during treatment. In-center dialysis precludes social
                distancing because it involves being in close proximity (https://www.jhunewsletter.com/article/2020/09/hopkins-finds-dialysis-patients-at-greater-risk-of-covid-19.
                 \171\ CJASN March 2021, 16 (3) 452-455; DOI: https://doi.org/10.2215/CJN.12360720.
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                 Dialysis health care personnel are considered a priority population
                for vaccination by the Advisory Committee on Immunization Practices
                (ACIP), yet ESRD facilities are currently reporting low COVID-19
                vaccination coverage among ESRD facility health care personnel, at less
                than 63 percent as of September 26, 2021.\172\ Ensuring health care
                personnel have access to COVID-19 vaccination is critical to protect
                both them and their medically fragile patients.\173\
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                 \172\ http://www.synas.plus/nhsn/covid19/dial-vaccination-dashboard.html#anchor_1594393306.
                 \173\ https://www.cdc.gov/vaccines/covid-19/planning/vaccinate-dialysis-patients-hcp.html, accessed 09/08/2021 22:00 EDT.
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                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 494.30(b)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (includes employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                2. Community Mental Health Centers (CMHCs)
                 CMHCs are entities that meet applicable enrollment requirements,
                and applicable licensing or certification requirements in the State in
                which they are located. CMHCs provide the set of mental health care
                services specified in section 1913(c)(1) of the PHS Act (or, in limited
                circumstances, provides for such service by contract with an approved
                organization or entity). Section 4162 of the Omnibus Budget
                Reconciliation Act of 1990 (Pub. L. 101-508, enacted November 5, 1990)
                (OBRA 1990), which added sections 1861(ff) and 1832(a)(2)(J) to the
                Act, includes CMHCs as entities that are authorized to provide partial
                hospitalization services under Part B of the Medicare program,
                [[Page 61579]]
                effective for services provided on or after October 1, 1991. Section
                1861(ff)(3)(B)(iv)(I) of the Act specifically requires CMHCs providing
                partial hospitalization services under Medicare to meet such additional
                conditions as the Secretary specifies to ensure the health and safety
                of individuals being furnished such services. Section 1866(e)(2) of the
                Act and 42 CFR 489.2(c)(2) recognize CMHCs as providers of services for
                purposes of provider agreement requirements but only with respect to
                providing partial hospitalization services. Pursuant to 42 CFR 410.2
                and 410.110, a CMHC may receive Medicare payment for partial
                hospitalization services only if it demonstrates that it provides the
                core services identified in the requirements. To qualify for Medicare
                reimbursement, CMHCs must comply with requirements for coverage of
                partial hospitalization services at Sec. 410.110 and conditions for
                Medicare payment of partial hospitalization services at 42 CFR
                424.24(e).
                 Currently there are 129 Medicare-certified CMHCs in the U.S. The
                Secretary has established in regulations, at 42 CFR part 485, subpart
                J, the minimum health and safety standards a CMHC must meet to obtain
                Medicare certification. CMHC CoPs were issued on October 29, 2013 (78
                FR 64604). Section 485.904, Personnel qualifications, establishes
                requirements for CMHC personnel. In this IFC we are adding new Sec.
                485.904(c) which requires the CMHC to meet the same COVID-19
                vaccination of staff requirements as those we are issuing for the other
                providers and suppliers affected by this rule.
                 CMHCs provide mental health services to treat patients under the
                Medicare partial hospitalization program and other patients for various
                mental health conditions. Partial hospitalization programs provide
                structured, outpatient mental health services that are more intense
                than office visits with physicians or therapists. Patients in partial
                hospitalization programs receive treatment for several hours during the
                day, multiple days a week. In response to the PHE, CMHCs continued to
                treat patients by using telecommunications, and some centers paused
                their partial hospitalization programs or reduced the frequency and
                duration of treatment. However, many centers have begun to see and
                treat patients in person again and have resumed their customary partial
                hospitalization programming schedules. With increased in-person
                services being offered in the CMHC, it is essential to ensure all staff
                are vaccinated against COVID-19 not only to protect themselves but to
                prevent the spread of COVID-19 to CMHC patients.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                485.904(c) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (includes employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                3. Comprehensive Outpatient Rehabilitation Facilities (CORFs)
                 CORFs are non-residential facilities that are established and
                operated exclusively for the purpose of providing diagnostic,
                therapeutic, and restorative services to outpatients for the
                rehabilitation of injured persons, sick persons, and persons with
                disabilities, at a single fixed location, by or under the supervision
                of a physician. In response to the PHE, outpatient rehabilitation
                facilities suspended operations, reduced their patient care capacity,
                and transitioned from in-person to telecommunications as able. However,
                certain rehabilitation services require physical contact with patients,
                such as fitting or adjusting a prosthesis or assistive device and
                assessing strength with manual resistance. During the pandemic, some
                patients in need of rehabilitation chose to delay care and others
                encountered delays in accessing care. These delays likely contributed
                to increased disability or illness.\174\ Moreover, patients admitted to
                the hospital have been discharged as soon as possible to provide beds
                for individuals with more critical conditions, including COVID-19. For
                those patients recovering from severe COVID-19 illness with long-term
                symptoms, prompt comprehensive outpatient rehabilitation services upon
                their discharge from inpatient care is necessary to restore physical
                and mental health.\175\ All of these factors stress the importance of
                rehabilitation facilities who are treating patients with increased
                morbidity and complex needs. CORFs have resumed operations and are
                providing services to an increasing number of patients; therefore,
                COVID-19 vaccination of staff is pivotal for inhibiting spread of
                infection and ensuring health and safety of patients.
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                 \174\ https://gh.bmj.com/content/bmjgh/5/5/e002670.full.pdf.
                Accessed 9/23/2021.
                 \175\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7027a2.htm?s_cid=mm7027a2_w Accessed 9/23/2021.
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                 Currently, there are 159 Medicare-certified CORFs in the U.S.
                Section 1861(cc)(2)(J) of the Act states that the CORF must ``meet such
                conditions of participation as the Secretary may find necessary in the
                interest of the health and safety of individuals who are furnished
                services by such facility, including conditions concerning
                qualifications of personnel in these facilities.'' Under this
                authority, the Secretary has established in regulations, at 42 CFR part
                485, subpart B, the minimum health and safety standards a CORF must
                meet to obtain Medicare certification. The CORF Conditions of
                Participation were issued on December 15, 1982 (47 FR 56282). Section
                485.70, Personnel qualifications, sets forth the qualifications that
                various personnel must meet, as a condition of participation. We are
                adding a new paragraph (n) at Sec. 485.70 which requires the CORF to
                meet the same COVID-19 vaccination of staff requirements as those we
                are issuing for the other providers and suppliers identified in this
                rule.
                 Our rules at Sec. 485.58(d)(4), state that personnel that do not
                meet the qualifications specified in Sec. 485.70 may be used by the
                facility in assisting qualified staff. We recognize this sentence is
                inconsistent with newly added Sec. 485.70(n) which requires
                vaccination of all facility staff. We also recognize that assisting
                personnel are used by CORFs. We established our requirements at Sec.
                485.70 (a) through (m) to provide a role for personnel that might not
                meet our education and experience qualifications. We do not believe
                that this exception for employees that do not meet our professional
                requirements should prohibit us from issuing staff qualifications
                referencing infection prevention, which we intend to apply to all
                personnel. Hence, we are revising Sec. 485.58(d)(4) to state that
                personnel that do not meet the qualifications specified in Sec.
                485.70(a) through (m) may be used by the facility in assisting
                qualified staff. However, such assisting staff will not be exempt from
                the newly added requirements in paragraph (n).
                 As with other parallel regulations for our facilities, we are
                revising Sec. 485.58(d)(4) as previously discussed. For these reasons
                and the reasons set forth in section II.A. of this IFC, we are adding a
                new regulatory requirement at Sec. 485.70(n) related to establishing
                and implementing policies and procedures for COVID-19 vaccination of
                all staff (includes employees; licensed practitioner; students,
                trainees, and volunteers; and other individuals) who provide care,
                treatment, or other services for the provider or its patients.
                [[Page 61580]]
                4. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
                (FQHCs)
                 Section 1861(aa) and 1905(l)(2)(B) of the Act sets forth the RHC
                and FQHC services covered by the Medicare program; section 1905(l)
                cross-references the Medicare provision for Medicaid program purposes.
                The Act requires that RHCs be located in an area that is both rural and
                underserved, are not rehabilitation agencies or facilities primarily
                for the care and treatment of mental diseases, and meet such other
                requirements as the Secretary may find necessary in the interest of the
                health and safety of the individuals who are furnished services by the
                clinic. Likewise, 42 CFR 491.2 defines a FQHC as an entity as defined
                in Sec. 405.2401(b). The definition at Sec. 405.2401 includes an
                entity that has entered into an agreement with CMS to meet Medicare
                Program requirements under Sec. 405.2434. And at 42 CFR 405.2434, the
                content and terms of the agreement require FQHCs to maintain compliance
                with requirements set forth in part 491, except the provisions of Sec.
                491.3 Certification procedures. Conditions for certification for RHCs
                and Conditions of Coverage for FQHCs are found at 42 CFR part 491,
                subpart A.
                 RHCs and FQHCs, as essential contributors to the health care
                infrastructure in the U.S., provide care and services to medically
                underserved areas and populations. They play a critical role in helping
                to alleviate access to care barriers and health equity gaps in these
                communities. RHCs and FQHCs provide primary care, diagnostic
                laboratory, and immunization services, and they have incorporated
                COVID-19 screening, triage, testing, diagnosis, treatment, and
                vaccination into these services. However, the medically underserved
                communities in the U.S. have been disproportionately affected by COVID-
                19. Hence, the Health Resources and Services Administration (HRSA) has
                established new programs to help RHCs and FQHCs meet the needs of their
                communities and ensure continuity of health care services during the
                PHE.176 177 178 For example: (1) The Rural Health Clinic
                COVID-19 Testing and Mitigation Program which helps RHCs with COVID-19
                testing and mitigation strategies to prevent the spread of infection;
                (2) the Rural Health Clinic Vaccine Distribution Program which
                strengthens COVID-19 vaccine allocations for RHCs; (3) the Rural Health
                Clinic Vaccine Confidence Program that helps RHCs with outreach efforts
                to improve vaccination rates in rural areas with nearly 2,000 RHCs
                across the nation participating; (4) the Health Center COVID-19 Vaccine
                Program whereby FQHCs receive direct allocations of vaccines; (5) the
                Department of Defense (DoD) and HHS partnered to provide point-of-care
                rapid COVID-19 testing supplies to FQHCs through the Health Center
                COVID-19 Testing Supply Distribution Program; and (6) delivery of 5.1
                million adult and 7.4 million child masks between April and August 2021
                to FQHCs at no cost for subsequent distribution to patients, staff, and
                community members. To implement these programs and to provide services
                and care, RHC/FQHC staff must interact with patients and members of the
                community at large. Hence, a requirement for these staff to receive
                COVID-19 vaccination is necessary to assure health and safety for the
                individuals residing in their respective service areas and their
                patients.
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                 \176\ https://www.hrsa.gov/coronavirus/rural-health-clinics.
                Accessed 9/24/2021.
                 \177\ https://bphc.hrsa.gov/emergency-response/coronavirus-frequently-asked-questions. Accessed 9/24/2021.
                 \178\ https://www.hrsa.gov/coronavirus/health-center-program.
                Accessed 10/6/2021.
                ---------------------------------------------------------------------------
                 Currently, there are 4,933 Medicare-and Medicaid-certified RHCs and
                10,384 FQHCs that participate in the Medicare and Medicaid programs in
                the U.S. The Conditions at 42 CFR part 491, subpart A are the minimum
                health and safety standards a center or clinic must meet to participate
                in the Medicare and Medicaid programs. The conditions were issued on
                June 12, 1992 (57 FR 27106), and the conditions related to staffing and
                staff responsibilities were last updated on May 12, 2014 (79 FR 27106).
                Section 491.8, Staffing and staff responsibilities, establishes
                requirements for RHC and FQHC staffing and staff responsibilities. We
                are adding new Sec. 491.8(d) which requires the clinic or center to
                meet the same COVID-19 vaccination of staff requirements as those we
                are issuing for the other providers and suppliers identified in this
                rule.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 491.8(d)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (includes employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                5. Clinics, Rehabilitation Agencies, and Public Health Agencies as
                Providers of Outpatient Physical Therapy and Speech-Language Pathology
                Services
                 Under the authority of section 1861(p) of the Act, the Secretary
                has established CoPs that clinics, rehabilitation agencies, and public
                health agencies (collectively, ``organizations'') must meet when they
                provide outpatient physical therapy (OPT) and speech-language pathology
                (SLP) services. Under section 1861(p) of the Act, the Secretary is
                responsible for ensuring that the CoPs and their enforcement are
                adequate to protect the health and safety of individuals receiving OPT
                and SLP services from these entities. The CoPs are set forth at 42 CFR
                part 485, subpart H. Section 1861(p) of the Act describes outpatient
                physical therapy services to mean physical therapy services furnished
                by a provider of services, a clinic, rehabilitation agency, or a public
                health agency, or by others under an arrangement with, and under the
                supervision of, such provider, clinic, rehabilitation agency, or public
                health agency to an individual as an outpatient. The patient must be
                under the care of a physician. The term ``outpatient physical therapy
                services'' also includes physical therapy services furnished to an
                individual by a physical therapist (in the physical therapist's office
                or the patient's home) who meets licensing and other standards
                prescribed by the Secretary in regulations, other than under
                arrangement with and under the supervision of a provider of services,
                clinic, rehabilitation agency, or public health agency. Pursuant to the
                statutory requirement set out at section 1861(p)(4)(A) and (B) of the
                Act, the furnishing of such services by a clinic, rehabilitation
                agency, or public health agency must meet such conditions relating to
                health and safety as the Secretary may find necessary. The term also
                includes SLP services furnished by a provider of services, a clinic,
                rehabilitation agency, or by a public health agency, or by others under
                an arrangement.
                 Currently, there are 2,078 clinics, rehabilitation agencies, and
                public health agencies that provide outpatient physical therapy and
                speech-language services. In the remainder of this rule and throughout
                the requirements, we use the term ``organizations'' instead of
                ``clinics, rehabilitation agencies, and public health agencies as
                providers of outpatient physical therapy and speech-language pathology
                services'' for consistency with current regulatory language. Patients
                receive services from organizations due to loss of functional
                [[Page 61581]]
                ability associated with injury or illness. Hence, these patients
                experience episodic issues and seek care to restore their level of
                functioning and wellness to baseline. In response to the PHE,
                organizations experienced a reduction in patients. They supplemented
                in-person care with telecommunications. However, just over 50 percent
                of physical therapists report in-person care results in better outcomes
                than care provided virtually and the majority of patients are less
                satisfied with care received by telecommunications.\179\ Although the
                data is limited, we believe these findings are consistent with other
                therapeutic services including occupational therapy and speech
                pathology. Comprehensive assessment of balance, strength, range-of-
                motion, and proper exercise technique is supported by physical touch,
                and three-dimensional visualization of the patient. Organizations have
                begun seeing more patients, and those patients are presenting with more
                severe functional issues. Organizations care for patients recovering
                from COVID-19 and those who delayed receiving non-COVID-19 related care
                due to fears of exposure to illness after the onset of the pandemic.
                These factors underscore the need to ensure safety and health of
                individuals who receive care from organizations with a requirement for
                COVID-19 vaccination of staff.
                ---------------------------------------------------------------------------
                 \179\ American Physical Therapy Association. May 2021. Impact of
                COVID-19 on the Physical Therapy Profession Over One Year.
                ---------------------------------------------------------------------------
                 The CoPs for organizations at 42 CFR part 485, subpart H are the
                minimum health and safety standards an organization must meet to obtain
                Medicare certification. The CoPs were first issued May 21, 1976 (41 FR
                20863), and the Conditions related to infection control were last
                updated on September 29, 1995 (60 FR 50446). Section 485.725, Infection
                control, requires organizations to establish an infection-control
                committee with responsibility for overall infection control. We are
                adding new paragraph (f) to Sec. 485.725, which requires the
                organizations to meet the same COVID-19 vaccination of staff
                requirements as those we are issuing for the other providers and
                suppliers identified in this rule.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                485.725(f) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (includes employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                G. Home-Based Care
                 Home-based care providers provide necessary care and services for
                individuals who need ongoing therapeutic, and in some cases life-
                sustaining, care. These settings require that health care staff enter
                the patient's personal home (regardless of location in a private home,
                assisted living facility, or another setting) to provide services and
                care in person, thus exposing patients and other members of their
                household, to the staff. Home-based provider staff also often serve
                multiple patients in different homes in the same day, week, or month,
                which presents opportunities for transmission of infectious diseases
                across households. Because home-based providers work outside of a
                regulated health care facility, there is also the potential for staff
                to either not use the appropriate PPE or use it improperly because on-
                site oversight mechanisms are not in place, that could increase the
                risk of transmission of COVID-19 or other infectious diseases across
                households. We also believe these patients are especially vulnerable to
                COVID-19 due to receiving care in their homes. Many patients have
                serious illnesses that increases the risk of morbidity and mortality
                from COVID-19. For hospice patients that are receiving non-curative but
                supportive care, we are concerned that contracting COVID-19 could
                increase their discomfort, decrease their quality of life, or perhaps
                even hasten their death. In addition, the patients' homes may have poor
                ventilation or members of the household may not be complying with
                recommended safety precautions. Thus, COVID-19 vaccination mandates
                will provide patients and their household members with safety
                assurances that will facilitate acceptance of home care services, and
                will protect the patients, staff, and the other members of the
                patients' households.
                1. Home Health Agencies (HHAs)
                 Under the authority of sections 1861(m), 1861(o), and 1891 of the
                Act, the Secretary has established in regulations the requirements that
                a home health agency (HHA) must meet to participate in the Medicare
                program, our regulations at 42 CFR 440.70(d) require that Medicaid-
                participating home health agencies meet Medicare conditions of
                participation. Section 1861(o)(6) of the Act requires that home health
                agencies ``meet the conditions of participation specified in section
                1891(a) and such other conditions of participation as the Secretary may
                find necessary in the interest of the health and safety of individuals
                who are furnished services by such agency or organization.'' The CoPs
                for home health services are found in Title 42, Part 484, subparts A
                through C, Sec. Sec. 484.40 through 484.115. HHAs provide care and
                services for qualifying older adults and people with disabilities who
                are beneficiaries under the Hospital Insurance (Part A) and
                Supplemental Medical Insurance (Part B) benefits of the Medicare
                program. These services include skilled nursing care, physical,
                occupational, and speech therapy, medical social work and home health
                aide services which must be furnished by, or under arrangement with, an
                HHA that participates in the Medicare program and must be provided in
                the beneficiary's home. As of September 1, 2021, there were 11,649 HHAs
                participating in the Medicare program. The majority of HHAs are for-
                profit, privately owned agencies. The effective delivery of quality
                home health services is essential to the care of the HHA's patients to
                provide necessary care and services and prevent hospitalizations. Since
                patients and other members of their households will be exposed to HHA
                staff, it is essential that staff be vaccinated against COVID-19 for
                the safety of the patients, members of their households, and the staff
                themselves.
                 With so many patients depending on the services of HHAs nationwide,
                it is imperative that HHAs have processes in place to address the
                safety of patients and staff and the continued provision of services.
                Because these patients are at home, essential care must be provided,
                regardless of COVID-19 vaccination or infection status. In addition, by
                going into patients' homes, HHA employees are exposed to numerous
                individuals who might not be vaccinated or perhaps are asymptomatic but
                infected. Therefore, it is imperative that HHAs have appropriate
                procedures to ensure the continued provision of care and services for
                their patients. Section 484.70 Condition of participation: Infection
                prevention and control (a) requires that the ``HHA must follow accepted
                standards of practice, including the use of standard precautions, to
                prevent the transmission of infections and communicable diseases.''
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 484.70(d)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (includes employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who
                [[Page 61582]]
                provide care, treatment, or other services for the provider or its
                patients.
                2. Hospice
                 Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982
                (Pub. L. 97-248, enacted September 3. 1982) (TEFRA), added section
                1861(dd) to the Act to provide coverage for hospice care to terminally
                ill Medicare beneficiaries who elect to receive care from a Medicare-
                participating hospice. Under the authority of section 1861(dd) of the
                Act, the Secretary has established the CoPs that a hospice must meet in
                order to participate in Medicare and Medicaid. Under section
                1861(dd)(2)(G) of the Act, the Secretary may impose ``such requirements
                as the Secretary may find necessary in the interest of the health and
                safety of the individuals who are provided care and services by such
                agency or organization.'' The CoPs found at part 418, subparts C and D
                apply to a hospice, as well as to the services furnished to each
                patient under hospice care. These requirements are set forth in
                Sec. Sec. 418.52 through 418.116.
                 Hospice care provides palliative care rather than curative
                treatment to terminally ill patients. Palliative care improves the
                quality of life of patients and their families and caregivers facing
                the challenges associated with terminal illness through the prevention
                and relief of suffering by means of early identification, assessment,
                and treatment of pain and other issues. Hospice care allows the patient
                to remain at home by providing support to the patient and family and
                caregiver and by keeping the patient as comfortable as possible while
                maintaining his or her dignity and quality of life. Hospices use an
                interdisciplinary approach to deliver medical, social, physical,
                emotional, and spiritual services through the use of a broad spectrum
                of support.
                 Hospices are unique health care providers because they serve
                patients, families, and caregivers in a wide variety of settings.
                Hospice patients may be served in their place of residence, whether
                that residence is a private home, an LTC facility, an assisted living
                facility, or even a recreational vehicle, as long as such locations are
                determined to be the patient's place of residence. Hospice patients may
                also be served in inpatient facilities, including those operated by the
                hospice itself.
                 With so many patients depending on the services of hospice services
                nationwide, it is imperative that hospices have processes in place to
                address the safety of patients and staff and the continued provision of
                services. The goal of hospice care is to provide non-curative, but
                supportive care of an individual during the final days, weeks, or
                months of a terminal illness. Contracting any infectious disease,
                especially COVID-19, could result in additional pain or perhaps even
                accelerate a patient's death. Thus, it is critical that hospices
                protect patients and staff from contracting or transmitting COVID-19.
                As of September 1, 2021, there were 5,556 hospices. Section 418.60(a),
                Condition of participation: Infection Control, requires that the
                ``hospice must follow accepted standards of practice to prevent the
                transmission of infections and communicable disease, including the use
                of standard precautions.''
                 The effective delivery of hospice services is essential to the care
                of the hospice's patients and their families and caregivers. Since
                patients and other members of their households will be exposed to
                hospice staff, it is essential that staff be vaccinated against COVID-
                19 for the safety of the patients, members of their households, and the
                staff themselves.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec. 418.60(d)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (including employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                3. Home Infusion Therapy Suppliers (HIT) Suppliers
                 Section 5012 of the 21st Century Cures Act (Pub. L. 114-255,
                enacted December 13, 2016) (Cures Act) created a separate Medicare Part
                B benefit category under 1861(s)(2)(GG) of the Act for coverage of home
                infusion therapy-associated professional services for certain drugs and
                biologicals administered intravenously or subcutaneously for periods of
                15 minutes or more in the patient's home through a pump that is an item
                of durable medical equipment. Section 1861(iii)(3)(D)(i)(IV) of the Act
                requires qualified home infusion therapy (HIT) suppliers to meet, in
                addition to specified qualifications, ``such other requirements as the
                Secretary determines appropriate.'' The regulatory requirements for
                home therapy infusion (HIT) suppliers are located at 42 CFR part 486,
                subpart I, Sec. Sec. 486.500 through 486.525.
                 The nature of the home setting presents different challenges than
                in-center services as well as the administration of the particular
                medications. The items and equipment needed to perform home infusion
                include the drug (for example, immune globulin), equipment (a pump),
                and supplies (for example, tubing and catheters) which are covered
                under the Durable Medical Equipment benefit. Skilled professional
                visits, such as those from nurses, often play a critical role in the
                provision of home infusion and are covered under the home infusion
                therapy benefit. For example, nurses typically train the patient or
                caregiver to self-administer the drug, educate on side effects and
                goals of therapy, and visit periodically to provide catheter and site
                care. Depending on patient acuity or the complexity of the drug
                administration, certain skilled professional visits may require more
                time. The HIT infusion process typically requires coordination among
                multiple entities, including patients, the responsible physicians and
                practitioners, hospital discharge planners, pharmacies, and, if
                applicable, home health agencies.
                 The current requirements for HIT suppliers do not contain specific
                infection prevention and control requirements. However, Sec. 486.525,
                Required services, does state that these providers must ``provide home
                infusion therapy services in accordance with nationally recognized
                standards of practice, and in accordance with all applicable state and
                federal laws and regulations.'' We believe that ``nationally recognized
                standards of practice'' include appropriate policies and procedures for
                infection prevention and control.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding a new regulatory requirement at Sec.
                486.525(c) related to establishing and implementing policies and
                procedures for COVID-19 vaccination of all staff (includes employees;
                licensed practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services for the
                provider or its patients.
                4. Programs of All-Inclusive Care for the Elderly (PACE) Organizations
                 The Programs of All-Inclusive Care for the Elderly (PACE) program
                provides a model of managed care service delivery for frail older
                adults, most of whom are dually eligible for Medicare and Medicaid
                benefits, and all of whom are assessed as being eligible for LTC
                facility placement according to the Medicaid standards established by
                their respective states. PACE organizations furnish comprehensive
                medical, health, and social services that integrate acute and long-term
                care, and these services must be furnished in at least the PACE
                [[Page 61583]]
                center, the home, and inpatient facilities. The PACE model involves a
                multidisciplinary team of providers known as the interdisciplinary team
                (IDT) that comprehensively assesses and meets the needs of each PACE
                participant by planning and coordinating all participant care. PACE
                organizations must provide all Medicare-covered items and services, all
                Medicaid-covered items and services, and any other services determined
                necessary by the IDT to improve and maintain the participant's overall
                health status, either directly or under contract with third party
                service providers.
                 The statutory authorities that permit Medicare payments and
                coverage of benefits under the PACE program, as well as the
                establishment of PACE organizations as a State option under Medicaid to
                provide for Medicaid payments and coverage of benefits under the PACE
                program, are under sections 1894 and 1934 of the Act. These statutory
                authorities are implemented at 42 CFR part 460, where CMS has set out
                the minimum requirements an entity must meet to operate a PACE program
                under Medicare and Medicaid.
                 There are 141 PACE organizations nationally. These organizations
                serve approximately 52,000 participants, all in need of the
                comprehensive services provided by PACE organizations. Due to their
                health status, PACE participants are at high risk of severe COVID-19
                and as such have been among the populations prioritized for vaccination
                since the vaccines were authorized. Participants' regular interactions
                with PACE organization staff and contractors indicate that those staff
                and contractors should also be vaccinated against COVID-19.
                 For these reasons and the reasons set forth in section II.A. of
                this IFC, we are adding new regulatory requirements at Sec. 460.74(d)
                related to establishing and implementing policies and procedures for
                COVID-19 vaccination of all staff (includes employees; licensed
                practitioner; students, trainees, and volunteers; and other
                individuals) who provide care, treatment, or other services on behalf
                of a PACE organization.
                III. Waiver of Proposed Rulemaking
                 We ordinarily publish a notice of proposed rulemaking in the
                Federal Register and invite public comment on the proposed rule before
                the provisions of the rule take effect, in accordance with the
                Administrative Procedure Act (APA), 5 U.S.C. 553, and section 1871 of
                the Act. Specifically, section 553(b) of the APA requires the agency to
                publish a notice of the proposed rule in the Federal Register that
                includes a reference to the legal authority under which the rule is
                proposed, and the terms and substance of the proposed rule or a
                description of the subjects and issues involved. Section 553(c) further
                requires the agency to give interested parties the opportunity to
                participate in the rulemaking through public comment before the
                provisions of the rule take effect. Similarly, section 1871(b)(1) of
                the Act requires the Secretary to provide for notice of the proposed
                rule in the Federal Register and a period of not less than 60 days for
                public comment. Section 553(b)(B) of the APA and section 1871(b)(2)(C)
                of the Act authorize the agency to waive these procedures, however, if
                the agency finds good cause that notice and comment procedures are
                impracticable, unnecessary, or contrary to the public interest and
                incorporates a statement of the finding and its reasons in the rule
                issued.
                 The 2021 outbreaks associated with the SARS-Cov-2 Delta variant
                have shown that current levels of COVID-19 vaccination coverage up
                until now have been inadequate to protect health care consumers and
                staff. The data showing the vital importance of vaccination indicate to
                us that we cannot delay taking this action in order to protect the
                health and safety of millions of people receiving critical health care
                services, the workers providing care, and our fellow citizens living
                and working in communities across the nation.
                 Although section 564 of the FDCA does not prohibit public or
                private entities from imposing vaccination requirements, even when the
                only vaccines available are those authorized under EUAs (https://www.justice.gov/olc/file/1415446/download), CMS initially chose, among
                other actions, to encourage rather than mandate vaccination, believing
                that a combination of other Federal actions, a variety of public
                education campaigns, and State and employer-based efforts would be
                adequate. However, despite all of these efforts, including CMS's
                mandate for vaccination education and offering of vaccines to LTC
                facility and ICF-IID staff, residents, and clients (86 FR 26306),
                OSHA's June 21, 2021 ETS to protect health care and health care support
                service workers from occupational exposure to COVID-19 (86 FR 3276),
                and ongoing CDC information and encouragement, vaccine uptake among
                health care staff has not been as robust as hoped for and have been
                insufficient to protect the health and safety of individuals receiving
                health care services from Medicare- and Medicaid-certified providers
                and suppliers, particularly given the advent of the Delta variant and
                the potential for new variants.
                 As discussed throughout the preamble of this IFC, the PHE continues
                to strain the U.S. health care system. Over the first 6 months of 2021,
                COVID-19 cases, hospitalizations and deaths declined. The emergence of
                the Delta variant reversed these trends.\180\ Between late June 2021
                and September 2021, daily cases of COVID-19 increased over 1200
                percent; new hospital admissions, over 600 percent; and daily deaths,
                by nearly 800 percent.\181\ Available data also continue to suggest
                that the majority of COVID-19 cases and hospitalizations are occurring
                among individuals who are not fully vaccinated. From January through
                May 2021, of the more than 32,000 laboratory-confirmed COVID-19-
                associated hospitalizations in adults over 18 years of age for whom
                vaccination status is known, less than 3 percent of hospitalizations
                occurred in fully vaccinated persons.\182\ More recently published data
                continue to suggest that fully vaccinated persons account for a
                minority (~10 percent) of COVID-19 related hospitalizations.\183\ For
                all adults aged 18 years and older, the cumulative COVID-19-associated
                hospitalization rate was about 12-times higher in unvaccinated
                persons.\184\ Consequently, some hospitals and health care systems are
                currently experiencing tremendous strain due to high case volume
                coupled with persistent staffing shortages due, at least in part, to
                COVID-19 infection or quarantine following exposure.
                ---------------------------------------------------------------------------
                 \180\ https://emergency.cdc.gov/han/2021/han00447.asp.
                 \181\ Internal estimates based on data published at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html;
                accessed September 24, 2021.
                 \182\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html,
                accessed October 18, 2021.
                 \183\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w, accessed October 18, 2021.
                 \184\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination, accessed October 18, 2021.
                ---------------------------------------------------------------------------
                 We recognize that newly reported COVID-19 cases, hospitalizations,
                and deaths have begun to trend downward at a national level;
                nonetheless, they remain substantially elevated relative to numbers
                seen in May and June 2021, when the Delta variant became the
                predominant strain circulating in the U.S.\185\ And while cases are
                trending
                [[Page 61584]]
                downward in some states, there are emerging indications of potential
                increases in others--particularly northern states where the weather has
                begun to turn colder. This is not surprising: Respiratory virus
                infections typically circulate more frequently during the winter
                months, with peaks in pneumonia and influenza deaths typically during
                winter months.\186\ Similarly, the U.S. experienced a large COVID-19
                wave in the winter of 2020. Approximately 1 in 3 people 12 years of age
                and older in the U.S. remain unvaccinated--and they could pose a threat
                to the country's progress on the COVID-19 pandemic, potentially
                incurring a fifth wave of COVID-19 infections.\187\
                ---------------------------------------------------------------------------
                 \185\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
                 \186\ https://www.cdc.gov/flu/professionals/acip/background-epidemiology.htm.
                 \187\ Ibid.
                ---------------------------------------------------------------------------
                 The onset of the 2021-2022 influenza season presents an additional
                threat to patient health and safety. Although influenza activity during
                the 2020-2021 season was low throughout the U.S.,\188\ the intensity of
                the upcoming 2021-2022 influenza season cannot be predicted. Several
                factors could make this flu season more severe; these include return to
                school by children with no prior exposure to flu (and therefor lower
                immunity), waning protection over time from previous seasonal influenza
                vaccination, and the fact that adult immunity (especially among those
                who were not vaccinated last season) will now partly depend on exposure
                to viruses two or more seasons earlier.189 190 COVID-19
                vaccination thus remains an important tool for decreasing stress on the
                U.S. health care system during ongoing circulation of influenza. As
                previously noted, health system strain can adversely impact patient
                access to care and care quality.
                ---------------------------------------------------------------------------
                 \188\ CDC. FluView. Weekly influenza surveillance report.
                Atlanta, GA: U.S. Department of Health and Human Services, CDC.
                Accessed February 11, 2021. https://www.cdc.gov/flu/weekly/index.htm.
                 \189\ https://www.medrxiv.org/content/10.1101/2021.08.29.21262803v1.
                 \190\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7029a1.htm.
                ---------------------------------------------------------------------------
                 Furthermore, data on the health consequences of coinfection with
                influenza and SARS-CoV-2 are limited. Preliminary evidence suggests
                that a combination of infections with influenza and SARS-CoV-2 would
                result in more severe health outcomes for patients than either
                infection alone.191 192 193 However, COVID-19 is more
                infectious and has greater rates of mortality, hospitalizations, and
                severe illness than influenza. Accordingly, it is imperative that the
                risk for healthcare-associated COVID-19 transmission be minimized
                during the influenza season. Influenza is most common during the fall
                and winter with the highest incidence of cases reported between
                December through March.\194\ COVID-19 vaccines require time after
                administration for the body to build an immune response. Hence, given
                that the influenza season is imminent, a staff COVID-19 vaccination
                requirement for the providers and suppliers identified in this rule
                cannot be further delayed. The impact of unvaccinated populations on
                the health-care system and the inconsistent web of State, local, and
                employer COVID-19 vaccination requirements have established a pressing
                need for a consistent Federal policy mandating staff vaccination in
                health care settings that receive Medicare and Medicaid funds. The
                current patchwork of regulations undermines the efficacy of COVID-19
                vaccine mandates by encouraging unvaccinated workers to seek employment
                at providers that do not have such patient protections, exacerbating
                staffing shortages, and creating disparities in care across
                populations. This includes workers moving between various types of
                providers, such as from LTC facilities to HHAs and others, creating
                imbalances. As discussed in section I. of this IFC, we have received
                numerous requests from diverse stakeholders for Federal intervention to
                implement a health-care staff vaccine mandate.\195\ Of particular note,
                several representatives of the long-term care community (not limited to
                Medicare- and Medicaid-certified LTC facilities) expressed concerns
                about inequities that would result from imposition of a mandate on only
                one type of provider and strongly recommended a broad approach.\196\
                While there is opposition to the vaccine mandate, a combination of
                factors now have persuaded us that a vaccine mandate for health care
                workers is an essential component of the nation's COVID-19 response,
                the delay of which would contribute to additional negative health
                outcomes for patients including loss of life. These include, but are
                not limited to, the following: Failure to achieve sufficiently high
                levels of vaccination based on voluntary efforts and patchwork
                requirements; ongoing risk of new COVID-19 variants; potential harmful
                impact of unvaccinated healthcare workers on patients; continuing
                strain on the health care system, particularly from Delta-variant-
                driven surging case counts beginning in summer 2021; demonstrated
                efficacy, safety and real-world effectiveness of available vaccines;
                FDA's full licensure of the Pfizer-BioNTech's Comirnaty vaccine; our
                observations of the efficacy of COVID-19 vaccine mandates in other
                settings; and the calls from numerous stakeholders for Federal
                intervention. Moreover, a further delay in imposing a vaccine mandate
                would endanger the health and safety of additional patients and be
                contrary to the public interest.
                ---------------------------------------------------------------------------
                 \191\ https://academic.oup.com/cid/article/72/12/e993/6024509?login=true.
                 \192\ https://onlinelibrary.wiley.com/doi/epdf/10.1002/jmv.26163.
                 \193\ https://www.cdc.gov/flu/about/season/flu-season.htm.
                 \194\ Ibid.
                 \195\ https://www.aamc.org/news-insights/press-releases/major-health-care-professional-organizations-call-covid-19-vaccine-mandates-all-health-workers. Accessed 10/06/2021.
                 \196\ https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2021/. Accessed 10/06/2021.
                ---------------------------------------------------------------------------
                 We note that health care workers were among the first groups
                provided access to vaccinations, which were initially authorized for
                emergency use. EUA status may have been a factor in some individual
                decisions to delay or refuse vaccination. The Pfizer-BioNTech COVID-19
                vaccine was first authorized for emergency use on December 11, 2020.
                The vaccine continues to be available in the U.S. under EUA, and the
                EUA was subsequently amended to include use in individuals 12 through
                15 years of age, to allow for the use of an additional dose in the
                primary series for certain immunocompromised individuals, and to allow
                for use of a single booster dose to be administered at least 6 months
                after completion of the primary series in certain individuals. FDA has
                issued EUAs for two additional vaccines for the prevention of COVID-19,
                one to Moderna (December 18, 2020) (indicated for use by individuals 18
                years of age and older), and the other to Janssen (Johnson & Johnson)
                (February 27, 2021) (indicated for use by individuals 18 years of age
                and older). Fact sheets for health care providers administering vaccine
                are available for each vaccine product from FDA. However, on August 23,
                2021, FDA licensed Pfizer-BioNTech's Comirnaty Vaccine. Health care
                workers whose hesitancy was related to EUA status now have a fully
                licensed COVID-19 vaccine option. Despite this, as noted earlier,
                health care staff vaccination rates remain sub-optimal in too many
                health care facilities and regions. For example, national COVID-19
                vaccination rates for LTC facility, hospital, and ESRD facility staff
                are 67 percent, 64 percent, and 60 percent, respectively. Moreover,
                these averages obscure sizeable regional differences.
                [[Page 61585]]
                LTC facility staff vaccination rates range from lows of 56 percent to
                highs of over 90 percent, depending upon the State. Similar patterns
                hold for ESRD facility and hospital staff.197 198 199
                ---------------------------------------------------------------------------
                 \197\ LTC facility rates derived from data reported through
                CDC's NHSN and posted online at the Nursing Home COVID-19
                Vaccination Data Dashboard: https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html; accessed September 15, 2021.
                 \198\ Dialysis facility rates derived from data reported through
                CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination
                Data Dashboard: https://www.cdc.gov/nhsn/covid19/dial-vaccination-dashboard.html; accessed September 15, 2021.
                 \199\ Hospital data come from unpublished analyses of data
                reported to HHS and posted on HHS Protect.
                ---------------------------------------------------------------------------
                 Over half a million COVID-19 cases and 1,900 deaths among health
                care staff have been reported to CDC since the start of the PHE.\200\
                When submitting case-level COVID-19 reports, State and territorial
                jurisdictions may identify whether individuals are or are not health
                care workers. Since health care worker status has only been reported
                for a minority of cases (approximately 18 percent), these numbers are
                likely gross underestimates of true burden in this population. COVID-19
                case rates among staff have also grown in tandem with broader national
                incidence trends since the Delta variant's emergence. For example, as
                of mid-September 2021, COVID-19 cases among LTC facility and ESRD
                facility staff have increased by over 1400 percent and 850 percent,
                respectively, since their lows in June 2021.\201\ Similarly, the number
                of cases among staff for whom case-level data were reported by State
                and territorial jurisdictions to CDC increased by nearly 600 percent
                between June and August 2021.\202\ Because they are at greater risk for
                developing COVID-19 infection and severe disease,203 204 205
                unvaccinated staff present a risk of exacerbating ongoing staffing
                shortages--particularly during periods of community surges in SARS-CoV-
                2 infection, when demand for health care services is most acute. Health
                care staff who remain unvaccinated may also pose a direct threat to
                patient, resident, workplace, family, and community safety and
                population health. Data from CDC's National Healthcare Safety Network
                (NHSN) have shown that case rates among LTC facility residents are
                higher in facilities with lower vaccination coverage among staff;
                specifically, residents of LTC facilities in which vaccination coverage
                of staff is 75 percent or lower experience higher crude rates of
                preventable SARS-CoV-2 infection.\206\ Similarly, several articles
                published in CDC's Morbidity and Mortality Weekly Reports (MMWRs)
                regarding nursing home outbreaks have also linked the spread of COVID-
                19 infection to unvaccinated health care workers and stressed that
                maintaining a high vaccination rate is important for reducing
                transmission.207 208 209 And multiple studies have
                demonstrated SARS-CoV-2 transmissions between health-care workers and
                patients in hospitals, despite universal masking and other
                protocols.210 211 212 213 Acute and LTC facilities engage
                many, if not all, of the same health care professionals and support
                services of other provider and supplier types. As a result, while
                similarly comprehensive data are not available for all Medicare- and
                Medicaid-certified provider and supplier types, we believe the LTC
                facilities experience may generally be extrapolated to other settings.
                ---------------------------------------------------------------------------
                 \200\ https://covid.cdc.gov/covid-data-tracker/#health-care-personnel; accessed September 24, 2021.
                 \201\ Analysis of dialysis facility and nursing home data
                reported through NHSN.
                 \202\ Ibid. 110.
                 \203\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
                 \204\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm?s_cid=mm7037e1_w.
                 \205\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
                 \206\ https://emergency.cdc.gov/han/2021/han00447.asp.
                 \207\ COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage
                Variant in a Skilled Nursing Facility After Vaccination Program--
                Kentucky, March 2021.'' April 21, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm.
                 \208\ Postvaccination SARS-CoV-2 Infections Among Skilled
                Nursing Facility Residents and Staff Members--Chicago, Illinois,
                December 2020-March 2021.'' April 30, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm.
                 \209\ Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine
                Among Residents of Two Skilled Nursing Facilities Experiencing
                COVID-19 Outbreaks--Connecticut, December 2020-February 2021.''
                March 19, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm.
                 \210\ Klompas M, Baker MA, Griesbach D, et al. Transmission of
                SARS-CoV-2 from asymptomatic and presymptomatic individuals in
                healthcare settings despite medical masks and eye protection. Clin
                Infect Dis. 2021. [PMID: 33704451] doi:10.1093/cid/ciab218.
                 \211\ https://www.medrxiv.org/content/10.1101/2021.02.16.21251625v1.
                 \212\ https://jamanetwork.com/journals/jama/fullarticle/2773128.
                 \213\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/.
                ---------------------------------------------------------------------------
                 The efficacy of COVID-19 vaccinations has been demonstrated.\214\
                An ASPE report published on October 5, 2021, found that COVID-19
                vaccines are a key component in controlling the COVID-19 pandemic.
                Clinical data show vaccines are highly effective in preventing COVID-19
                cases and severe outcomes including hospitalization and death. The ASPE
                analysis of individual-level health data and county-level vaccination
                rates found that higher county vaccination rates were associated with
                significant reductions in the odds of COVID-19 infection,
                hospitalization, and death among Medicare fee-for-service (FFS)
                beneficiaries between January and May 2021. Further, comparing the
                rates of these outcomes to what ASPE modeling predicted would have
                happened without any vaccinations, we estimate COVID-19 vaccinations
                were linked to estimated reductions of approximately 107,000
                infections, 43,000 hospitalizations, and 16,000 deaths in our study
                sample of 25.3 million beneficiaries. The report also noted that the
                difference in vaccination rates for those age 65 and older between the
                lowest (34 percent) and highest (85 percent) counties and states by the
                end of May highlights the continued opportunity to leverage COVID-19
                vaccinations to prevent COVID-19 hospitalizations and deaths.\215\
                Vaccines continue to be effective in preventing COVID-19 associated
                with the now-dominant Delta variant.216 217
                ---------------------------------------------------------------------------
                 \214\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
                 \215\ https://aspe.hhs.gov/sites/default/files/documents/c5d0dde224c224dd726694367846b609/aspe-covid-medicare-vaccine-analysis.pdf. Accessed 10/06/2021.
                 \216\ https://www.nejm.org/doi/full/10.1056/nejmoa2108891.
                 \217\ https://www.mayoclinic.org/coronavirus-covid-19/covid-variant-vaccine.
                 \218\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
                 \219\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
                ---------------------------------------------------------------------------
                 In addition to preventing morbidity and mortality associated with
                COVID-19, the vaccines also appear to be effective against asymptomatic
                SARS-CoV-2 infection. A recent study of health care workers in 8 states
                found that, between December 14, 2020, through August 14, 2021, full
                vaccination with COVID-19 vaccines was 80 percent effective in
                preventing RT-PCR-confirmed SARS-CoV-2 infection among frontline
                workers.\218\ Emerging evidence also suggests that vaccinated people
                who become infected with Delta have potential to be less infectious
                than infected unvaccinated people, thus decreasing transmission
                risk.\219\ For example, in a study of breakthrough infections among
                health care workers in the Netherlands, SARS-CoV-2 infectious virus
                shedding was lower among vaccinated individuals with breakthrough
                infections than
                [[Page 61586]]
                among unvaccinated individuals with primary infections.\220\
                ---------------------------------------------------------------------------
                 \220\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
                ---------------------------------------------------------------------------
                 As noted earlier in this section, a combination of factors,
                including but not limited to failure to achieve sufficiently high
                levels of vaccination based on voluntary efforts and patchwork
                requirements, potential harm to patients from unvaccinated health-care
                workers, and continuing strain on the health care system and known
                efficacy and safety of available vaccines, have persuaded us that a
                vaccine mandate for health care workers is an essential component of
                the nation's COVID-19 response. Further, it would endanger the health
                and safety of patients, and be contrary to the public interest to delay
                imposing it. Therefore, we believe it would be impracticable and
                contrary to the public interest for us to undertake normal notice and
                comment procedures and to thereby delay the effective date of this IFC.
                We find good cause to waive notice of proposed rulemaking under the
                APA, 5 U.S.C. 553(b)(B), and section 1871(b)(2)(C) of the Act. For
                those same reasons, as authorized by the Small Business Regulatory
                Enforcement Fairness Act of 1996 (the Congressional Review Act or CRA),
                5 U.S.C. 808(2), we find it is impracticable and contrary to the public
                interest not to waive the delay in effective date of this IFC under
                section 801 of the CRA. Therefore, we find there is good cause to waive
                the CRA's delay in effective date pursuant to section 808(2) of the
                CRA.
                IV. Collection of Information Requirements
                 Under the Paperwork Reduction Act of 1995 (PRA), we are required to
                provide 30-day notice in the Federal Register and solicit public
                comment before a collection of information requirement (ICR) is
                submitted to the Office of Management and Budget (OMB) for review and
                approval. The ICRs in this section will be included in an emergency
                revision of the information collection request currently approved under
                the appropriate OMB Control number. All PRA-related comments received
                in response to this IFC will be reviewed and addressed in a subsequent,
                non-emergency, submission of the information collection request. The
                emergency approval is only valid for 6 months. Within that 6-month
                approval period, CMS will seek a regular, non-emergency, approval and
                as required by the PRA, this action will be announced in the requisite
                60-day and 30-day Federal Register notices.
                 In order to fairly evaluate whether an information collection
                should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
                Reduction Act of 1995 requires that we solicit comment on the following
                issues:
                 The need for the information collection and its usefulness
                in carrying out the proper functions of our agency.
                 The accuracy of our estimate of the information collection
                burden.
                 The quality, utility, and clarity of the information to be
                collected.
                 Recommendations to minimize the information collection
                burden on the affected public, including automated collection
                techniques.
                 We are soliciting public comment on each of these issues for the
                following sections of this document that contain information collection
                requirements (ICRs):
                 For the estimated costs contained in the analysis below, we used
                data from the U.S. Bureau of Labor Statistics (BLS) to determine the
                mean hourly wage for the positions used in this analysis.\221\ For the
                total hourly cost, we doubled the mean hourly wage for a 100 percent
                increase to cover overhead and fringe benefits, according to standard
                HHS estimating procedures. If the total cost after doubling resulted in
                0.50 or more, the cost was rounded up to the next dollar. If it was
                0.49 or below, the total cost was rounded down to the next dollar. The
                total costs used in this analysis are indicated in Table 3.
                ---------------------------------------------------------------------------
                 \221\ BLS. May 2020 National Occupational Employment and Wage
                Estimates United States. United States Department of Labor. Accessed
                at https://www.bls.gov/oes/current/oes_nat.htm. Accessed on August
                25, 2021.
                ---------------------------------------------------------------------------
                BILLING CODE 4120-01-P
                [[Page 61587]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.024
                [[Page 61588]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.025
                BILLING CODE 4120-01-C
                 In this analysis, we used specific resources to estimate the burden
                for the providers and suppliers in this rule. Based upon our
                experience, there are minimal fluctuations in the numbers of providers
                and suppliers monthly. Thus, unless otherwise indicated, all of the
                numbers for the providers and suppliers in this analysis were located
                on September 1, 2021 on the Quality, Certification & Oversight Reports
                (QCOR) website at https://qcor.cms.gov/main.jsp. For the number of
                employees for each provider and supplier, those numbers were obtained
                from Table 5: Estimates of Number of Staff by Type of Provider
                (thousands) located in section VI.B. of this IFC.
                 This analysis is also based upon certain assumptions. We believe
                that many of the providers and suppliers covered in this rule have
                already either encouraged their employees to get
                [[Page 61589]]
                vaccinated for COVID-19 or have mandates for the vaccine. Mandates for
                employees to be vaccinated for COVID-19 can result from State, county,
                or local actions or result from a decision by the facility. These
                facilities would likely have already developed policies and procedures,
                as well as documentation requirements, related to their employees being
                vaccinated for COVID-19. However, we have no reliable method to
                estimate the number or percentage of these facilities. In addition, it
                is likely that those facilities would not comply with all of the
                requirements in this rule. For example, many facilities might not
                define ``employees'' as set forth in this rule. Each facility would
                have to review its policies, procedures, and documentation requirements
                to ensure that they comply with the requirements in this rule. Hence,
                based upon these assumptions, this analysis will assess the burden for
                all facilities and employees for each provider and supplier type.
                 We also made some assumption regarding analysis of the burden for
                the documentation requirements. If an employee receives the appropriate
                vaccinations, reviewing and documenting that the employee has been
                vaccinated would likely only require 1 to 3 minutes, depending upon how
                the facility is documenting the vaccination, which is likely to vary
                substantially between facilities. However, for employees that request
                exemptions or have to be contacted repeatedly for the appropriate
                documentation, it would likely take more time to comply with this
                requirement. At a minimum, both the initial request for the exemption
                and the final determination would have to be documented. In cases where
                the exemption was denied and the employee receives the appropriate
                vaccinations, those vaccine doses would also have to be documented.
                There might also be additional documentation that would need to be
                copied or scanned for their records. While the documentation for
                employees requesting an exemption would require more burden, we believe
                that there would only be a small percentage of employees that would
                request an exemption. Since we have no reliable method for estimating a
                number or percentage of employees who would be in each category, we
                will analyze the burden for the documentation requirements using 5
                minutes or 0.0833 hours for each employee.
                 The position of the individual who would perform the activities
                related to the documentation requirement would also vary depending upon
                the type of provider or supplier and whether the employee requested an
                exemption. If the employee has been vaccinated in compliance with this
                rule, an administrative support person might review their vaccination
                card and document that the employee has been vaccinated. However, if an
                administrative support person performs these activities, we believe an
                administrator or another member of the health care staff would be
                responsible for overseeing these activities. For other providers and
                suppliers, a nurse would likely be assigned to verify and document
                vaccination status. If an employee requests an exemption, we believe
                that a nurse, another health care professional, or an administrator
                would likely review the request and document it. Some other providers
                or suppliers might have an administrator or another member of the
                health care staff perform these activities. Thus, for this analysis, if
                a provider is required to have at least one infection preventionist
                (IP), such as hospitals, we believe the IP would be responsible for
                documenting the vaccination status for all employees. For other
                providers and suppliers, we assessed the burden using a registered
                nurse (RN), another member of the health care staff, such as a physical
                therapist, or an administrator.
                 The estimates that follow are largely based on our experience with
                these various providers. However, given the uncertainty and rapidly
                changing nature of the current pandemic, we acknowledge that there will
                likely need to be revisions to these requirements over time. We welcome
                comments that might improve these estimates.
                A. ICRs Regarding the of Development of Policies and Procedures for
                ASCs Sec. 416.51(c), ``COVID-19 Vaccination of Staff''
                1. Policies and Procedures
                 At Sec. 416.51(c), we require ASCs to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and track and maintain documentation of their vaccination status.
                Each ASC must also have a contingency plan for any staff that are not
                fully vaccinated according to this rule.
                 The ICRs for this section would require each ASC to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Based upon our experience with ASCs, we believe some
                centers have already developed policies and procedures requiring COVID-
                19 vaccination for staff. However, each ASC will need to review their
                current policies and procedures and modify them, if necessary, to
                ensure compliance with the requirements in this IFC, especially that
                their policies and procedures cover all of the center staff as
                identified in this IFC. Hence, we will base our estimate for this ICR
                on all 6,071 ASCs. We believe activities associated with this IFC would
                be performed by the RN functioning as the designated and qualified
                infection control professional (ICP) and ASC administrator as analyzed
                below.
                 The ICP would conduct research and then either modify or develop
                the policies and procedures needed to comply with this section's
                requirements. The ICP would work with the ASC administrator in
                developing these policies and procedures. For the ICP, we estimate this
                would require 8 hours initially to perform research and revise or
                develop the policies and procedures to meet these requirements.
                According to Table 3, the ICP's total hourly cost is $77. Thus, for
                each ASC, the burden for the ICP would be 8 hours at a cost of $616 (8
                x $77). For the ICPs in all 6,071 ASCs, the burden would be 48,568
                hours (8 x 6,071) at an estimated cost of $3,739,736 ($616 x 6,071).
                 As discussed above, the revision and approval of these initial
                policies and procedures would also require activities by the ASC
                administrator. The administrator would need to have meetings with the
                ICP to discuss the revisions and approve the final policies and
                procedures. We estimate this would require 2 hours for the
                administrator. According to Table 3, the total hourly cost for the
                administrator is $98. The burden for the administrator in each ASC
                would be 2 hours at an estimated cost of $196 (2 x $98). For the
                administrators in all 6,071 ASCs, the burden would be 12,142 hours (2 x
                6,071) at an estimated cost of $1,189,916 ($196 x 6,071).
                 Therefore, for all 6,071 ASCs, the estimated burden associated with
                the requirement for policies and procedures would be 67,010 hours
                (48,568 + 12,142) at a cost of $4,929,652 ($3,739,736 + $1,189,916).
                2. Documentation and Storage
                 Section 416.51(c) also requires ASCs to track and securely maintain
                the required documentation of staff COVID-19 vaccination status. Any
                burden for modifying the center's policies and procedures for these
                activities is already accounted for above. We believe that this would
                require an RN 5 minutes or 0.0833 hours to perform the required
                documentation an adjusted hourly wage of $77 for each employee.
                According to Table 3, ASCs have 200,000 employees.
                [[Page 61590]]
                Hence, the burden for these documentation requirements for all 6,071
                ASCs would be 16,660 (0.0833 x 200,000) hours at an estimated cost of
                $1,282,820 (16,660 x $77).
                 The total burden for all 6,071 ASCs for this IFC would be 83,670
                (67,010 + 16,660) hours at an estimated cost of $6,212,472 ($4,929,652
                + $1,282,820).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-0266 (expiration date July 31, 2024).
                B. ICRs Regarding the Development of Policies and Procedures for
                Hospices Sec. 418.60(d), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 At Sec. 418.60(d), we require hospices to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. The hospice must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each hospice to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Current regulations are set forth at Sec. 418.60
                Condition of participation: Infection control, and require each hospice
                to maintain and document an infection control program to prevent and
                control infections and communicable diseases. The hospice must also
                follow accepted standards of practice, including the use of standard
                precautions to prevent the transmission of infections and communicable
                diseases. Thus, all hospices should already have infection prevention
                and control policies and procedures, but they likely do not comply with
                all of the requirements in this IFC.
                 All hospices would need to review their current policies and
                procedures and modify them to comply with all of the requirements in
                Sec. 418.60(d) as set forth in this IFC. While we believe that many
                hospices have already addressed COVID-19 vaccination with their staff,
                we have no reliable means to estimate that number. Therefore, we will
                assess the burden for these requirements for all 5,556 hospices. We
                believe these activities would be performed by the RN and an
                administrator. According to Table 3, an RN in these settings has a
                total hourly cost of $79. Since there are not any current requirements
                that address COVID-19 vaccination, we estimate it would require 8 hours
                for the RN to research, draft, and work with an administrator to
                finalize the policies and procedures. Thus, for each hospice, the
                burden for the RN would be 8 hours at a cost of $632 (8 hours x $79).
                For all 5,556 hospices, the burden would be 44,448 hours (8 hours x
                5,556) at an estimated cost of $3,511,392 ($632 x 5,556).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator in this setting is $122. Hence, for each hospice,
                the burden would be 2 hours at an estimated cost of $244 (2 x $122).
                For all 5,556 hospices, the total burden would be 11,112 hours (2 x
                5,556) at an estimated cost of $1,355,664 (5,556 x $244).
                 Thus, the total burden for hospices to comply with the requirements
                for policies and procedures in this IFC is 55,560 hours (44,448 +
                11,112) at an estimated cost of $4,867,056 ($3,511,392 + $1,355,664).
                2. Documentation and Storage
                 Section 418.60(d) also requires hospices to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the hospice's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an RN 5 minutes or 0.0833 hours to perform the
                required documentation an adjusted hourly wage of $79 for each
                employee. According to Table 3, hospices have 340,000 employees. Hence,
                the burden for these documentation requirements for all 5,556 hospices
                would be 28,322 (0.0833 x 340,000) hours at an estimated cost of
                $2,237,438 (28,322 x 79).
                 Therefore, the total burden for all 5,556 hospices for this rule
                would be 83,882 (55,560 + 28,322) hours at an estimated cost of
                $7,104,494 (4,867,056 + 2,237,438).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1067 (expiration date March 31, 2024).
                C. ICRs Regarding the Development of Policies and Procedures for PACE
                Organizations Sec. 460.74(d), ``COVID-19 Vaccination of PACE
                Organization Staff''
                1. Policies and Procedures
                 Section 460.74(d) requires that programs for all-inclusive care for
                the elderly (PACE) organizations to develop and implement policies and
                procedures to ensure their staff are vaccinated for COVID-19 and that
                appropriate documentation of those vaccinations are tracked and
                maintained. Each PACE organization must also have a contingency plan
                for all staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each PACE organization to
                develop the policies and procedures needed to satisfy all of the
                requirements in this section. Current regulations at Sec. 460.74
                already require that each PACE organization follow accepted policies
                and standard procedures with respect to infection control in place.
                Thus, all PACE organizations should have policies and procedures
                regarding infection prevention and control. We also believe that many
                have already addressed COVID-19 vaccination policies for their staff.
                However, since we do not have a reliable method to estimate how many
                have, we will assess the burden for all 141 PACE organizations.
                 All PACE organizations would need to review their current infection
                prevention and control policies and procedures and develop or modify
                them to satisfy the requirements in this section. We believe these
                activities would require an RN and an administrator. According to Table
                3, an RN's total hourly cost is $74. Since there are not any current
                requirements that address COVID-19 vaccination, we estimate it would
                require 8 hours for the RN to research, draft, and work with an
                administrator to finalize the policies and procedures. Thus, for each
                PACE organization, the burden for the RN would be 8 hours at a cost of
                $592 (8 hours x $74). For all 141 PACE organizations, the burden would
                be 1,128 hours (8 hours x 141) at an estimated cost of $83,472 (592 x
                141).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator is $122. Hence, for each PACE organization, the
                burden would be 2 hours at an estimated cost of $244 (2 x 122). For all
                141 PACE organizations, the total burden would be 282 hours (2 x 141)
                at an estimated cost of $34,404 (141 x $244).
                 Thus, the total burden for all 141 PACE organizations to comply
                with the requirements for the policies and
                [[Page 61591]]
                procedures is 1,410 hours (1,128 + 282) at an estimated cost of
                $117,876 (83,472 + 34,404).
                2. Documentation and Storage
                 Section 460.74(d) also requires PACE organizations to track and
                securely maintain the required documentation of staff COVID-19
                vaccination status. Any burden for modifying the PACE organization's
                policies and procedures for these activities is already accounted for
                above. We believe that this would require an RN 5 minutes or 0.0833
                hours to perform the required documentation an adjusted hourly wage of
                $74 for each employee. According to Table 3, PACE organizations have
                10,000 employees. Hence, the burden for these documentation
                requirements for all 141 PACE organizations would be 833 (0.0833 x
                10,000) hours at an estimated cost of $61,642 (833 x 74).
                 Therefore, the total burden for all 141 PACE organizations for this
                rule would be 2,243 (1,410 + 833) hours at an estimated cost of
                $179,518 (117,876 + 61,642).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1326 (expiration date April 20, 2023).
                D. ICRs Regarding the Development of Policies and Procedures for
                Hospitals Sec. 482.42(g), ``COVID-19 Vaccination of Hospital Staff''
                1. Policies and Procedures
                 At Sec. 482.42(g), we require hospitals to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. The hospital must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each hospital to develop
                the policies and procedures needed to satisfy all of the requirements
                in this section. Current regulations at Sec. 482.42 Condition of
                participation: Infection prevention and control and antibiotic
                stewardship programs already require hospitals to have an infection
                prevention and control program (IPCP) and an infection preventionist
                (IP). The IPCP must have methods to prevent and control the
                transmission of infection within the hospital and between the hospital
                and other settings. Thus, all 5,194 hospitals should already have
                infection prevention and control policies and procedures. However, each
                hospital would need to review their current policies and procedures and
                modify them, if necessary, to ensure compliance with all of the
                requirements in this IFC, especially that their policies and procedures
                cover all of the eligible facility staff identified in this IFC. Based
                upon our experience with hospitals, we believe many hospitals have
                already developed policies and procedures requiring COVID-19
                vaccination for staff. Since we have no reliable means to estimate the
                number of hospitals that may have already addressed COVID-19
                vaccination of their staff, we will base our estimate for these
                requirements on all 5,194 hospitals.
                 We believe these activities would be performed by the IP, the
                director of nursing (DON), and an administrator. The IP would need to
                research COVID-19 vaccines, modify the policies and procedures, as
                necessary, and work with the DON and administrator to develop the
                policies and procedures and obtain appropriate approval. For the IP, we
                estimate these activities would require 8 hours. According to Table 3,
                the IP's total hourly cost is $79. Thus, for each hospital, the burden
                for the IP would be 8 hours at a cost of $632 (8 hours x 79). For the
                IPs in all 5,194 hospitals, the burden would be 41,552 hours (8 hours x
                5,194) at an estimated cost of $3,282,608 (632 x 5,194).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by the DON and an
                administrator. We believe these activities would require 2 hours each
                for the DON and an administrator. According to Table 3, the total
                adjusted hourly wage for both the DON and an administrator is $122.
                Hence, for each hospital, the burden would be 4 hours (2 x 2) at an
                estimated cost of $488 (4 x $122). The total burden for all 5,194
                hospitals would be 20,776 hours (4 x 5,194) at an estimated cost of
                $2,534,672 (5,194 x 488).
                 Therefore, for all 5,194 hospitals, the total burden for the
                requirements for policies and procedures is 62,328 hours (41,552 +
                20,776) at an estimated cost of $5,817,280 (3,282,608 + 2,534,672).
                2. Documentation and Storage
                 Section 482.42(g) also requires hospitals to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the hospital's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an RN 5 minutes or 0.0833 hours to perform the
                required documentation an adjusted hourly wage of $79 for each
                employee. According to Table 3, hospitals have 6,070,000 employees. We
                could not locate a reliable number for critical access hospital (CAH)
                employees so they are included here with the hospital employees. Hence,
                the burden for these documentation requirements for all 5,194 hospital
                and 1,358 CAHs would be 505,631 (0.0833 x 6,070,000) hours at an
                estimated cost of $39,944,849 (505,631 x 79).
                 Therefore, the total burden for this rule for all 5,194 hospitals
                and 1,358 CAHs (documentation burden only) would be 567,959 (62,328 +
                505,631) hours at an estimated cost of $45,762,129 (5,817,280 +
                39,944,849).
                 The requirements and burden will be submitted to OMB as an
                emergency reinstatement of an existing OMB control number 0938-0328.
                E. ICRs Regarding the Development of Policies and Procedures for LTC
                Facilities Sec. 483.80(i), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 At Sec. 483.80(i), we require LTC facilities to develop and
                implement policies and procedures to ensure their staff are vaccinated
                for COVID-19 and that appropriate documentation of those vaccinations
                are tracked and maintained. The LTC facility must also have a
                contingency plan for all staff not fully vaccinated according to this
                rule.
                 The ICRs for this section would require each LTC facility to
                develop the policies and procedures needed to satisfy all of the
                requirements in this section. Current regulations at Sec. 483.80(d)(1)
                and (2) already require LTC facilities to have policies and procedures
                to educate, offer, and document vaccination status for residents
                regarding the influenza and pneumococcal immunizations. In addition,
                Sec. 483.80(d)(3) requires LTC facilities to educate, offer, and
                document the vaccination status for residents and staff for the COVID-
                19 immunizations. Based upon our experience with LTC facilities, we
                believe some facilities have already developed policies and procedures
                requiring COVID-19 vaccination for staff, including COVID-19 vaccine
                mandates. However, we have no reliable means to estimate the number or
                percentage of LTC facilities that have already mandated vaccination.
                Hence, we will base our estimate for this ICR on all 15,401 LTC
                facilities.
                 Each LTC facility would need to review its policies and procedures
                for Sec. 483.80(d) and modify them to comply with the requirements in
                this rule at Sec. 483.80(i) and obtain the appropriate review and
                approval. This would require conducting research and revising the
                policies and procedures as needed. We believe these activities
                [[Page 61592]]
                would be performed by the infection preventionist (IP), director of
                nursing (DON), and medical director for the first year and the IP in
                subsequent years as analyzed below.
                 The IP would need to work with the DON and medical director to
                revise and finalize the policies and procedures. For the IP, we
                estimate this would require 2 hours initially to perform research and
                revise the policies and procedures to meet these requirements.
                According to Table 3, the IP's total hourly cost is $69. Thus, for each
                LTC facility, the burden for the IP would be 2 hours at a cost of $138
                (2 hours x 69). For the IPs in all 15,401 LTC facilities, the burden
                would be 30,802 hours (2 hours x 15,401 facilities) at an estimated
                cost of $2,125,338 (138 x 15,401).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by the DON and medical
                director. Both the DON and medical director would need to have meetings
                with the IP to discuss the revision, evaluation, and approval of the
                policies and procedures. We estimate this would require 1 hour for both
                the DON and medical director. According to Table 3, the total hourly
                cost for the DON is $96. The burden in the first year for the DON in
                each LTC facility would be 1 hour at an estimated cost of $96 (1 hour x
                96). The burden would be 15,401 hours (1 x 15,401) at an estimated cost
                of $1,478,496 (96 x 15,401) for all LTC facilities.
                 For the medical director, we have estimated the revision of
                policies and procedures would also require 1 hour. According to the
                chart above, the total hourly cost for the medical director is $171.
                For each LTC facility, this would require 1 hour for the medical
                director during the first year at an estimated cost of $171 (1 hour x
                $171). the burden for all LTC facilities would be 15,401 hours (1 x
                15,401) at an estimated cost of $2,633,571 (171 x 15,401).
                 Therefore, for all 15,401 LTC facilities in the first year, the
                estimated burden for the policies and procedures requirement would be
                61,604 hours (30,802 + 15,401 + 15,401) at a cost of $6,237,405
                (2,125,338 + 1,478,496 + 2,633,571).
                2. Documentation and Storage
                 Section 483.80(i) also requires LTC facilities to track and
                securely maintain the required documentation of staff COVID-19
                vaccination status. Any burden for modifying the facility's policies
                and procedures for these activities is already accounted for above. The
                PRA package submitted under OMB Control No. 0938-1363 already provides
                for the documentation burden for the IP for the LTC facility's
                infection prevention and control program (IPCP) under which the
                requirements in this rule will also be located. We believe the burden
                for the documentation requirements in this rule should be included in
                that burden. Therefore, we will not assess any additional burden for
                the documentation requirements in this rule.
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1363 (expiration date June 30, 2022).
                F. ICRs Regarding the Development of Policies and Procedures for PRTFs
                Sec. 441.151(c), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 Section 441.151(c) requires psychiatric residential treatment
                facilities (PRTFs) to develop and implement policies and procedures to
                ensure their staff are vaccinated for COVID-19 and that appropriate
                documentation of those vaccinations are tracked and maintained. The
                PRTF must also have a contingency plan for all staff not fully
                vaccinated according to this rule.
                 The ICRs for this section would require each PRTF to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Current regulations for PRTFs do not address infection
                prevention and control or vaccinations. Hence, although we believe that
                at least some PRTFs have already addressed COVID-19 vaccination of
                their staff, we will assess the burden for all 357 PRTFs.
                 We believe these activities would be performed by an RN and an
                administrator. According to Table 3, an RN's total hourly cost is $74.
                Since there are not any current requirements that address COVID-19
                vaccination, we estimate it would require 8 hours for the RN to
                research, draft, and work with an administrator to finalize the
                policies and procedures. Thus, for each PRTF, the burden for the RN
                would be 8 hours at a cost of $592 (8 hours x 74). For all 357 PRTFs,
                the burden would be 2,856 hours (8 hours x 357) at an estimated cost of
                $211,344 (592 x 357).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator is $122. Hence, for each PRTF, the burden would
                be 2 hours at an estimated cost of $244 (2 x 122). For all 357 PRTFs,
                the total burden would be 714 hours (2 x 357) at an estimated cost of
                $87,108 (357 x 244).
                 Thus, the total burden for all 357 PRTFs to comply with the
                policies and procedures requirements in this IFC for policies and
                procedures is 3,570 hours (2,856 + 714) at an estimated cost of
                $298,452 (211,344 + 87,108).
                2. Documentation and Storage
                 Section 441.151(c) also requires PRTFs to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the facility's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an RN 5 minutes or 0.0833 hours to perform the
                required documentation an adjusted hourly wage of $74 for each
                employee. According to Table 3, PRTFs have 30,000 employees. Hence, the
                burden for these documentation requirements for all 357 PRTFs would be
                2,499 (0.0833 x 30,000) hours at an estimated cost of $184,926 (2,499 x
                74).
                 Therefore, the total burden for all 357 PRTFs for this rule would
                be 6,069 (3,570 + 2,499) hours at an estimated cost of $483,378
                (298,452 + 184,926)
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-0833 (expiration date May 31, 2022).
                G. ICRs Regarding the Development of Policies and Procedures for ICFs-
                IID Sec. 483.430(f), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 At Sec. 483.430(f), we require ICFs-IID to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. The ICFs-IID must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each ICFs-IID to develop
                the policies and procedures needed to satisfy all of the requirements
                in this section. Current regulations at Sec. 483.470(l) Standard:
                Infection control requires that the ICFs-IID must provide a sanitary
                environment to avoid sources and transmission of infections. The
                facility must also implement successful corrective action in affected
                problem areas, maintain a record of incidents and corrective actions
                related to infections, and prohibit employees with symptoms or sign of
                a communicable
                [[Page 61593]]
                disease from direct contact with clients and their food. Hence, ICFs-
                IID should already have policies and procedures for infection
                prevention and control.
                 We believe these activities would be performed by the RN. According
                to Table 3, an RN's total hourly cost is $69. Since there are not any
                current requirements that address COVID-19 vaccination, we estimate it
                would require 8 hours for the RN to research, draft, and work with an
                administrator to finalize the policies and procedures. Thus, for each
                ICFs-IID, the burden for the RN would be 8 hours at a cost of $552 (8
                hours x 69). For all 5,780 ICFs-IID, the burden would be 46,240 hours
                (8 hours x 5,780) at an estimated cost of $3,190,560 (552 x 5,780).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator is $96. Hence, for each ICFs-IID, the burden
                would be 2 hours at an estimated cost of $192 (2 x 96). For all 5,780
                ICFs-IID, the total burden would be 11,560 hours (2 x 5,780) at an
                estimated cost of $1,109,760 (5,780 x 192).
                 Thus, the total burden for all 5,780 ICFs-IID to comply with the
                requirements for policies and procedures is 57,800 hours (46,240 +
                11,560) at an estimated cost of $4,300,320 (3,190,560 + 1,109,760).
                2. Documentation and Storage
                 Section 483.430(f) also requires ICFs-IID to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the facility's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an RN 5 minutes or 0.0833 hours to perform the
                required documentation at adjusted hourly wage of $69 for each
                employee. According to Table 3, ICFs-IID have 80,000 employees. Hence,
                the burden for these documentation requirements for all 5,780 ICFs-IID
                would be 6,664 (0.0833 x 80,000) hours at an estimated cost of $459,816
                (6,664 x $69).
                 Therefore, the total burden for all 5,780 ICFs-IID for this rule
                would be 64,464 (57,800 + 6,664) hours at an estimated cost of
                $4,760,136 (4,300,320 + 459,816).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1402 (expiration date September 30, 2024).
                H. ICRs Regarding the Development of Policies and Procedures for HHAs
                Sec. 484.70(d), ``COVID-19 Vaccination of Home Health Agency Staff''
                1. Policies and Procedures
                 At Sec. 483.70(d), we require HHAs to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. The HHA must also have a contingency plan for all staff
                not fully vaccinated according to this rule.
                 The ICRs for this section would require each HHA to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Current regulations at Sec. 483.70, Condition of
                participation: Infection prevention and control require each HHA to
                maintain and document an infection control program to prevent and
                control infections and communicable diseases. The HHA must follow
                accepted standards of practice, including the use of standard
                precautions to prevent the transmission of infections and communicable
                diseases. Thus, all HHA should already have infection prevent and
                control policies and procedures, but they likely do not comply with all
                of the requirements in this IFC.
                 All HHAs would need to review their current policies and procedures
                and modify them to comply with all of the requirements in Sec.
                483.70(d), as set forth in this IFC. While we believe that many HHAs
                have already addressed COVID-19 vaccination with their staff, we have
                no reliable means to estimate that number. Therefore, we will assess
                the burden for these requirements for all 11,649 HHAs. We believe these
                activities would be performed by the RN and an administrator. According
                to Table 3, an RN in home health services total hourly cost is $73.
                Since there are not any current requirements that address COVID-19
                vaccination, we estimate it would require 8 hours for the RN to
                research, draft, and work with an administrator to finalize the
                policies and procedures. Thus, for each HHA, the burden for the RN
                would be 8 hours at a cost of $584 (8 hours x 73). For all 11,649 HHAs,
                the burden would be 93,192 hours (8 hours x 11,649) at an estimated
                cost of $6,803,016 (584 x 11,649).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator in home health services is $97. Hence, for each
                HHA, the burden would be 2 hours at an estimated cost of $194 (2 x 97).
                For all 11,649 HHAs, the total burden would be 23,298 hours (2 x
                11,649) at an estimated cost of $2,259,906 (11,649 x 194).
                 Thus, the total burden for all 11,649 HHAs to comply with the
                policies and procedures requirements for policies and procedures is
                116,490 hours (93,192 + 23,298) at an estimated cost of $9,062,922
                (6,803,016 + 2,259,906).
                2. Documentation and Storage
                 Section 483.70(d) also requires HHAs to track and securely maintain
                the required documentation of staff COVID-19 vaccination status. Any
                burden for modifying the agency's policies and procedures for these
                activities is already accounted for above. We believe that this would
                require an RN 5 minutes or 0.0833 hours to perform the required
                documentation at adjusted hourly wage of $73 for each employee.
                According to Table 3, HHAs have 2,110,000 employees. Hence, the burden
                for these documentation requirements for all 11,649 HHAs would be
                175,763 (0.0833 x 2,110,000) hours at an estimated cost of $12,830,699
                (175,763 x 73).
                 Therefore, the total burden for all 11,649 HHAs for this rule would
                be 292,253 (116,490 + 175,763) hours at an estimated cost of
                $21,893,621 (9,062,922 + 12,830,699).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1299 (expiration date June 30, 2024).
                I. ICRs Regarding the Development of Policies and Procedures for CORFs
                Sec. 485.70(n), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 At Sec. 485.70(n), we require CORFs to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. Each CORF must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each CORF to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. This IFC requires CORF staff to receive the COVID-19
                vaccine unless medically contraindicated as determined by a physician,
                advance practice registered nurse, or physician
                [[Page 61594]]
                assistant acting within their respective scope of practice as defined
                by and in accordance with all applicable State and local laws. Based
                upon our experience with CORFs, we believe some facilities have already
                developed policies and procedures requiring COVID-19 vaccination for
                staff unless medically contraindicated. However, each CORF will need to
                review their current policies and procedures and modify them, if
                necessary, to ensure compliance with the requirements in this IFC,
                especially that their policies and procedures cover all of the
                organization staff identified in this IFC. Hence, we will base our
                estimate for this ICR on all 159 CORFs. The CORF's governing body
                appoints an administrator who implements and enforces the facility's
                policies and procedures. Hence, we believe activities associated with
                this IFC would be performed by the administrator as analyzed below. The
                governing body would also need to review these policies and procedures,
                which would be included in its ``legal responsibility for establishing
                and implementing policies regarding the management and operation of the
                facility.''
                 The administrator would conduct research to either modify or
                develop policies and procedures. For the administrator, we estimate
                this would require 8 hours initially to perform research and revise or
                develop the policies and procedures to meet these requirements.
                According to Table 3, the administrator's total hourly cost is $98.
                Thus, for each CORF, the burden for the administrator would be 8 hours
                at a cost of $784 (8 x 98). For the administrators in all 159
                organizations, the burden would be 1,272 hours (8 x 159) at an
                estimated cost of $124,656 (784 x 159).
                 The administrator would need to spend time attending governing body
                meetings to discuss and obtain approval for the policies and
                procedures; however, that would be a usual and customary business
                practice. Therefore, activities for the administrator associated with
                governing body approval for the policies and procedures are exempt from
                the PRA in accordance with 5 CFR 1320.3(b)(2).
                2. Documentation and Storage
                 Section 485.70(n) also requires CORFs to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the facility's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an administrator 5 minutes or 0.0833 hours to
                perform the required documentation at adjusted hourly wage of $98 for
                each employee. According to Table 3, CORFs have 10,000 employees.
                Hence, the burden for these documentation requirements for all 159
                CORFs would be 833 (0.0833 x 10,000) hours at an estimated cost of
                $81,634 (833 x 98).
                 Therefore, the total burden for all 159 CORFs for this rule would
                be 2,105 (1,272 + 833) hours at an estimated cost of $206,290 (124,656
                + 81,634).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1091 (expiration date November 30, 2022).
                J. ICRs Regarding the Development of Policies and Procedures for CAHs
                Sec. 485.640(f), ``COVID-19 Vaccination of CAH Staff''
                1. Policies and Procedures
                 At Sec. 485.640(f), we require critical access hospitals (CAHs) to
                develop and implement policies and procedures to ensure their staff are
                vaccinated for COVID-19 and that appropriate documentation of those
                vaccinations are tracked and maintained. The CAH must also have a
                contingency plan for all staff not fully vaccinated according to this
                rule.
                 The ICRs for this section would require each CAH to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Current regulations at Sec. 485.640 Condition of
                participation: Infection prevention and control and antibiotic
                stewardship programs already require CAHs to have an infection
                prevention and control program (IPCP) and an infection preventionist
                (IP). The IPCP must have methods to prevent and control the
                transmission of infection within the hospital and between the hospital
                and other settings. Thus, all 1,358 CAHs should already have infection
                prevention and control policies and procedures. However, each CAH would
                need to review their current policies and procedures and modify them,
                if necessary, to ensure compliance with all of the requirements in this
                IFC, especially that their policies and procedures cover all of the
                eligible facility staff identified in this IFC. Based upon our
                experience with CAHs, we believe many CAHs have already developed
                policies and procedures requiring COVID-19 vaccination for staff. Since
                we have no reliable means to estimate the number of CAHs that may have
                already addressed COVID-19 vaccination of their staff, we will base our
                estimate for these requirements on all 1,358 CAHs.
                 We believe these activities would be performed by the IP, the
                director of nursing (DON), and an administrator. The IP would need to
                research COVID-19 vaccines, modify the policies and procedures, as
                necessary, and work with the DON and administrator to develop the
                policies and procedures and obtain appropriate approval. For the IP, we
                estimate these activities would require 8 hours. According to Table 3,
                the IP's total hourly cost is $79. Thus, for each hospital, the burden
                for the IP would be 8 hours at a cost of $632 (8 hours x 79). For the
                IPs in all 1,358 CAHs, the burden would be 10,864 hours (8 hours x
                1,358) at an estimated cost of $858,256 (632 x 1,358).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by the DON and an
                administrator. We believe these activities would require 2 hours each
                for the DON and an administrator. According to Table 3, the total
                adjusted hourly wage for both the DON and an administrator is $122.
                Hence, for each CAH the burden would be 4 hours (2 x 2) at an estimated
                cost of $488 (4 x $122). The total burden for all 1,358 CAHs would be
                5,432 hours (4 x 1,358) at an estimated cost of $662,704 (1,358 x 488).
                 Therefore, for all 1,358 CAHs the total burden for the requirements
                for policies and procedures is 16,296 hours (10,864 + 5,432) at an
                estimated cost of $1,520,960 ($858,256 + $662,704).
                2. Documentation and Storage
                 Section 485.640(f) also requires CAHs to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the CAH's policies and procedures for
                these activities is already accounted for above. Since we were unable
                to located a reliable number for CAH employees, the documentation
                burden for CAHs resulting from the documentation requirement in this
                rule is included in the hospitals' burden above.
                 The requirements and burden for CAHs without DPUs will be submitted
                to OMB under OMB control number 0938-1043 (expiration date March 31,
                2024). The requirements and burden for CAHs with DPUs will be submitted
                to OMB under OMB control number 0938-0328(expired).
                [[Page 61595]]
                K. ICRs Regarding the Development of Policies and Procedures for
                Clinics, Rehabilitation Agencies, and Public Health Agencies as
                Providers of Outpatient Physical Therapy and Speech-Language Pathology
                Services (Organizations) Sec. 485.725(f), ``COVID-19 Vaccination of
                Organization Staff''
                1. Policies and Procedures
                 At Sec. 485.725(f), we require organizations to develop and
                implement policies and procedures to ensure their staff are vaccinated
                for COVID-19 and the appropriate documentation is tracked and
                maintained. The organization must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each organization to
                develop the policies and procedures needed to satisfy all of the
                requirements in this section. Current regulations at Sec. 485.725(a)
                require organizations to establish an infection-control committee of
                representative professional staff with overall responsibility for
                infection control. This committee establishes policies and procedures
                for investigating, controlling, and preventing infections in the
                organization and monitors staff performance to ensure compliance with
                those policies and procedures. Based upon these requirements and our
                experience with organizations, we believe some organizations have
                already developed policies and procedures requiring COVID-19
                vaccination for staff unless medically contraindicated. However, since
                we have no reliable means to estimate how many organizations have done
                this, we will assess the burden for all 2,078 organizations. All
                organizations would need to review their current policies and
                procedures and modify them, if necessary, to ensure compliance with the
                requirements in this IFC.
                 The types of therapists at each organization vary depending upon
                the services offered. For the purposes of determining the COI burden,
                we will assume that the therapist is a physical therapist. We believe
                activities associated with this IFC would be performed by a physical
                therapist and administrator. A physical therapist would need to conduct
                research on the COVID-19 vaccines and then develop or modify policies
                and procedures that comply with the requirements in this IFC. The
                physical therapist would need to work with an administrator to make the
                necessary revisions. For the physical therapist, we estimate this would
                require 8 hours to perform research and revise or develop the policies
                and procedures to meet these requirements. According to Table 3, the
                physical therapist's total hourly cost is $84. Thus, for each
                organization, the burden for the physical therapist would be 8 hours at
                a cost of $672 (8 x 84). For the physical therapists in all 2,078
                organizations, the burden would be 16,624 hours (8 x 2,078) at an
                estimated cost of $1,396,416 (672 x 2,078).
                 As discussed above, the revision and approval of these policies and
                procedures would also require activities by the administrator. The
                administrator would need to have meetings with the physical therapist
                to discuss the revisions and draft any necessary policies and
                procedures, as well as approve the final policies and procedures. We
                estimate this would require 2 hours for the administrator. According to
                Table 3, the total hourly cost for the administrator is $98. The burden
                for the administrator in each organization would be 2 hours at an
                estimated cost of $196 (2 x 98). For the administrators in all 2,078
                organizations, the burden would be 4,156 hours (2 x 2,078) at an
                estimated cost of $407,288 (4,156 x 98).
                 Therefore, for all 2,078 organizations, the total burden for the
                requirements for policies and procedures is 20,780 hours (16,624 +
                4,156) at an estimated cost of $1,803,704 (1,396,416 + 407,288).
                2. Documentation and Storage
                 Section 485.725(f) also requires organizations to track and
                securely maintain the required documentation of staff COVID-19
                vaccination status. Any burden for modifying the organization's
                policies and procedures for these activities is already accounted for
                above. We believe that this would require a physical therapist 5
                minutes or 0.0833 hours to perform the required documentation at
                adjusted hourly wage of $84 for each employee. According to Table 3,
                these organizations have 10,000 employees. Hence, the burden for these
                documentation requirements for all 2,078 organizations would be 833
                (0.0833 x 10,000) hours at an estimated cost of $69,972 (833 x 84).
                 Therefore, the total burden for all 2,078 organizations for this
                rule would be 21,613 (20,780 + 833) hours at an estimated cost of
                $1,873,676 (1,803,704 + 69,972).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-0273 (expiration date June 30, 2024).
                L. ICRs Regarding the Development of Policies and Procedures for CMHCs
                Sec. 485.904(c), ``COVID-19 Vaccination of Center Staff''
                1. Policies and Procedures
                 At Sec. 485.904(c), we require CHMCs to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. Each facility must maintain documentation of their
                staff's vaccination status. Also, each facility must have a contingency
                plan for all staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each CHMC to develop the
                policies and procedures needed to satisfy all of the requirements in
                this section. Based upon our experience with CHMCs, we believe some
                centers have already developed policies and procedures requiring COVID-
                19 vaccination for staff unless medically contraindicated. However,
                since we do not have a reliable means to estimate how many CMHCs have
                done so, we will estimate the burden based on all 129 CHMCs.
                 Each CMHC will need to review their current policies and procedures
                and modify them, if necessary, to ensure compliance with the
                requirements in this IFC. Based on these requirements and our
                experience with CHMCs, we believe these activities would be performed
                by the CHMC administrator and a mental health counselor. The
                administrator would conduct research regarding the COVID-19 vaccines
                and then either modify or develop the policies and procedures necessary
                to comply with the requirements in this IFC. The administrator would
                send any recommendations for changes or additional policies or
                procedures to the mental health counselor. The administrator and mental
                health clinician would need to make the necessary revisions and draft
                any necessary policies and procedures. For the administrator, we
                estimate this would require 8 hours initially to perform research and
                revise or develop the policies and procedures to meet these
                requirements. According to Table 3, the administrator's total hourly
                cost is $113. Thus, for each CMHC, the burden for the administrator
                would be 8 hours at a cost of $904 (8 x 113). The burden for the
                administrators in all 129 CHMCs would be 1,032 hours (8 x 129) at an
                estimated cost of $116,616 (904 x 129).
                 As discussed above, the revision and approval of these initial
                policies and procedures would also require activities
                [[Page 61596]]
                by the mental health counselor. The administrator would need to have
                meetings with the mental health counselor to discuss the revisions and
                draft any necessary policies and procedures. We estimate this would
                require 2 hours for the mental health counselor. According to Table 3,
                the total hourly cost for the mental health counselor is $118. The
                burden for the mental health counselor in each CHMC would be 2 hours at
                an estimated cost of $236 (2 x 118). For the mental health counselors
                in all 129 CMHCs, the burden would be 258 hours (2 x 129) at an
                estimated cost of $30,444 (129 x 236).
                 Therefore, for all 129 CMHCs, the total burden for the requirements
                for policies and procedures is 1,290 hours (1,032 + 258) at an
                estimated cost of $147,060 (116,616 + 30,444).
                2. Documentation and Storage
                 Section 485.904(c) also requires CMHCs to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the center's policies and procedures
                for these activities is already accounted for above. We believe that
                this would require an administrator 5 minutes or 0.0833 hours to
                perform the required documentation at adjusted hourly wage of $113 for
                each employee. According to Table 3, CMHCs have 140,000 employees.
                Hence, the burden for these documentation requirements for all 129
                CMHCs would be 11,662 (0.0833 x 140,000) hours at an estimated cost of
                $1,317,806 (11,662 x 113).
                 Therefore, the total burden for all 129 CMHCs for this rule would
                be 12,952 (1,290 + 11,662) hours at an estimated cost of $1,464,866
                (147,060 + 1,317,806).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-1245 (expiration date April 30, 2023).
                M. ICRs Regarding the Development of Policies and Procedures for HIT
                Suppliers Sec. 486.525(c), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 Section 486.525(c) requires home infusion therapy (HIT) suppliers
                to develop and implement policies and procedures to ensure their staff
                are vaccinated for COVID-19 and that appropriate documentation of those
                vaccinations are tracked and maintained. The HIT supplier must also
                have a contingency plan for all staff not fully vaccinated according to
                this rule.
                 The ICRs for this section would require each HIT supplier to
                develop the policies and procedures needed to satisfy all of the
                requirements in this section. Current regulations at Sec. 486.525
                already require that HIT suppliers provide their services in accordance
                with nationally recognized standards of practice. Thus, we believe most
                HIT suppliers should already have infection prevention and control
                policies and procedures, including COVID-19 vaccination. However, we
                have no reliable means to estimate how many suppliers have done so.
                Thus, we will base our burden estimate on all 337 HIT suppliers.
                 All HIT suppliers would need to review their current policies and
                procedures and develop or modify them to comply with all of the
                requirements in Sec. 486.525(c) as set forth in this IFC. We believe
                these activities would be performed by the RN and an administrator
                working for the HIT supplier. According to Table 3, an RN working with
                for a HIT supplier would have a total hourly cost of $73. Since there
                are not any current requirements that address COVID-19 vaccination, we
                estimate it would require 8 hours for the RN to research, draft, and
                work with an administrator to finalize the policies and procedures.
                Thus, for each HIT supplier, the burden for the RN would be 8 hours at
                a cost of $584 (8 hours x 73). For all 337 HIT suppliers, the burden
                would be 2,696 hours (8 hours x 337) at an estimated cost of $24,601
                (337 x 73).
                 The development and/or revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator working for a HIT supplier is $97. Hence, for
                each HIT supplier, the burden would be 2 hours at an estimated cost of
                $194 (2 x 97). For all 337 HIT suppliers, the total burden for the
                administrator would be 674 hours (2 hours x 337) at an estimated cost
                of $65,378 (337 x 194).
                 Therefore, for all 337 HIT suppliers, the total burden for the
                requirements for policies and procedures is 3,370 hours (2,696 + 674)
                at an estimated cost of $89,979 (24,601 + 65,378).
                2. Documentation and Storage
                 Section 486.525(c) also requires HIT suppliers to track and
                securely maintain the required documentation of staff COVID-19
                vaccination status. Any burden for modifying the supplier's policies
                and procedures for these activities is already accounted for above. We
                believe that this would require an RN 5 minutes or 0.0833 hours to
                perform the required documentation at adjusted hourly wage of $73 for
                each employee. According to Table 3, HIT suppliers have 20,000
                employees. Hence, the burden for these documentation requirements for
                all 337 HIT suppliers would be 1,666 (0.0833 x 20,000) hours at an
                estimated cost of $121,618 (1,666 x 73).
                 Therefore, the total burden for all 337 HIT suppliers for this rule
                would be 5,036 (3,370 + 1,666) hours at an estimated cost of $211,597
                (89,979 + 121,618).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-855B (expiration date March 31, 2024).
                N. ICRs Regarding the Development of Policies and Procedures for RHCs
                and FQHCs Sec. 491.8(d), ``COVID-19 Vaccination of Staff''
                1. Policies and Procedures
                 At Sec. 491.8(d), we require RHCs/FQHCs to develop and implement
                policies and procedures to ensure their staff are vaccinated for COVID-
                19 and that appropriate documentation of those vaccinations are tracked
                and maintained. Each RHC/FQHC must also have a contingency plan for all
                staff not fully vaccinated according to this rule.
                 The ICRs for this section would require each RHC/FQHC to develop
                the policies and procedures needed to satisfy all of the requirements
                in this section. This IFC requires clinic or center staff to receive
                the COVID-19 vaccine unless medically contraindicated as determined by
                a physician, advance practice registered nurse, or physician assistant
                acting within their respective scope of practice as defined by and in
                accordance with all applicable State and local laws. Based upon
                experience with RHCs/FQHCs, we believe some clinics or centers have
                already developed policies and procedures requiring COVID-19
                vaccination for staff unless medically contraindicated. However, since
                we do not have a reliable means to estimate how many facilities have
                already done so, we will base the burden analysis for this estimate on
                all 15,317 RHC/FQHCs (4,933 RHCs and 10,384 FQHCs).
                 Each RHC/FQHC will need to review their current policies and
                procedures and modify them, if necessary, to ensure compliance with the
                requirements in this IFC, especially that their policies and procedures
                cover all of the clinic or center staff identified in this IFC. Current
                regulations require a physician,
                [[Page 61597]]
                nurse practitioner, and physician assistant to participate in the
                development, execution, and periodic review of the policies and
                procedures.\222\ Moreover, the RHC/FQHC operates under the medical
                direction of a physician. Based on these requirements and our
                experience with RHCs/FQHCs, we believe activities associated with this
                IFC would be performed by the RHC administrator, physician, nurse
                practitioner, physician assistant, and medical director as analyzed
                below.
                ---------------------------------------------------------------------------
                 \222\ 42 CFR 491.7.
                ---------------------------------------------------------------------------
                 The administrator would conduct research to either modify or
                develop policies and procedures. The administrator would send any
                recommendations for changes or additional policies or procedures to the
                physician, nurse practitioner, and physician assistant. The
                administrator, physician, nurse practitioner, and physician assistant
                would need to make the necessary revisions and draft any necessary
                policies and procedures. The administrator would need to work with the
                medical director to obtain approval for the policies and procedures to
                be implemented. For the administrator, we estimate this would require 8
                hours initially to perform research and revise or develop the policies
                and procedures to meet these requirements. According to Table 3, the
                administrator's total hourly cost is $108. Thus, for each RHC/FQHC, the
                burden for the administrator would be 8 hours at a cost of $864 (8 x
                108). For the administrators in all 15,317 RHCs/FQHCs, the burden would
                be 122,536 hours (8 x 15,317) at an estimated cost of $13,233,888 (864
                x 15,317).
                 As discussed above, the revision and approval of these initial
                policies and procedures would also require activities by the physician,
                nurse practitioner, physician assistant, and medical director. The
                administrator would need to have meetings with the physician, nurse
                practitioner, and physician assistant to discuss the revisions and
                draft any necessary policies and procedures. The administrator would
                also need to have meetings with the medical director to obtain approval
                for the policies and procedures. We estimate this would require 2 hours
                each for the physician, nurse practitioner, and physician assistant.
                For the medical director, we estimate 1 hour would be required to
                perform this function. According to Table 3, the total hourly cost for
                the physician is $212. The burden for the physician in each RHC/FQHC
                would be 2 hours at an estimated cost of $424 (2 x 212). For the
                physicians in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours
                (2 x 15,317) at an estimated cost of $6,494,408 (424 x 15,317). The
                hourly cost for the nurse practitioner is $107. The burden for the
                nurse practitioner in each RHC/FQHC would be 2 hours at an estimated
                cost of $214 (2 x 107). For the nurse practitioners in all 15,317 RHCs/
                FQHCs, the burden would be 30,634 hours (2 x 15,317) at an estimated
                cost of $3,277,838 ($214 x 15,317). The hourly cost for the physician
                assistant is $111. The burden for the physician assistant in each RHC/
                FQHC would be 2 hours at an estimated cost of $222 (2 x 111). For the
                physician assistants in all 15,317 RHCs/FQHCs, the burden would be
                30,634 hours (2 x 15,317) at an estimated cost of $3,400,374 (15,317 x
                222). The hourly cost for the medical director is $212. The burden for
                the medical director in each RHC/FQHC would be 1 hour at an estimated
                cost of $212. For the medical directors in all 15,317 RHCs/FQHCs, the
                burden would be 15,317 hours (1 x 15,317) at an estimated cost of
                $3,247,204 (15,317 x 212).
                 Therefore, for all 15,317 RHCs/FQHCs, the estimated burden
                associated with the policies and procedures requirement would be
                229,755 hours (122,536 + 30,634 + 30,634 + 30,634 + 15,317) at a cost
                of $29,653,712 (13,233,888 + 6,494,408 + 3,277,838 + 3,400,374 +
                3,247,204).
                2. Documentation and Storage
                 Section 491.8(d) also requires RHCs/FQHCs to track and securely
                maintain the required documentation of staff COVID-19 vaccination
                status. Any burden for modifying the clinic's or center's policies and
                procedures for these activities is already accounted for above. We
                believe that this would require an administrator 5 minutes or 0.0833
                hours to perform the required documentation at an adjusted hourly wage
                of $108 for each employee. According to Table 3, RHCs have 40,000
                employees and FQHCs have 110,000 employees for a total of 150,000
                employees. Hence, the burden for these documentation requirements for
                all 15,317 RHCs and FQHCs would be 12,495 (0.0833 x 150,000) hours at
                an estimated cost of $1,349,460 (12,495 x 108).
                 Therefore, the total burden for all 15,317 RHCs and FQHCs for this
                rule would be 242,250 (229,755 + 12,495) hours at an estimated cost of
                $31,003,172 (29,653,712 + 1,349,460).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-0334 (expiration date March 31, 2023).
                O. ICRs Regarding the Development of Policies and Procedures for ESRD
                Facilities Sec. 494.30(b), ``COVID-19 Vaccination of Facility Staff''
                1. Policies and Procedures
                 Section 494.30(b) requires the ESRD facilities to develop and
                implement policies and procedures to ensure their staff are vaccinated
                for COVID-19 and that appropriate documentation of those vaccinations
                are tracked and maintained. The ESRD facility must also have a
                contingency plan for all staff not fully vaccinated according to this
                rule.
                 The ICRs for this section would require each ESRD facility to
                develop the policies and procedures needed to satisfy all of the
                requirements in this section. Current regulations at Sec. 494.30
                already require that ESRD facilities follow standard infection control
                precautions. Thus, all ESRD facilities should have infection prevention
                and control policies and procedures. We believe that many ESRD
                facilities have already addressed COVID-19 vaccination for their staff.
                However, we have no reliable means to estimate how many ESRD facilities
                have done so. Thus, we will base our burden estimate on all 7,893 ESRD
                facilities.
                 All ESRD facilities would need to review their current policies and
                procedures and develop or modify them to comply with all of the
                requirements in Sec. 494.30(b) as set forth in this IFC. We believe
                these activities would be performed by the RN and an administrator.
                According to Table 3, an RN working with for an ESRD facility would
                have a total hourly cost of $73. Since there are not any current
                requirements that address COVID-19 vaccination, we estimate it would
                require 8 hours for the RN to research, draft, and work with an
                administrator to finalize the policies and procedures. Thus, for each
                ESRD facility, the burden for the RN would be 8 hours at a cost of $584
                (8 hours x $73). For all ESRD facilities, the burden would be 63,144
                hours (8 hours x 7,893) at an estimated cost of $4,609,512 (7,893 x
                584).
                 The development and/or revision and approval of these policies and
                procedures would also require activities by an administrator. The
                administrator would need to work with the RN to develop the policies
                and procedures, and then review and approve the changes. We estimate
                this would require 2 hours. According to Table 3, the total hourly cost
                for the administrator at an ESRD facility is $97. Hence, for each ESRD,
                the burden for the administrator would be 2 hours at an estimated cost
                of $194 (2 x 97). For all ESRD facilities, the total burden would be
                15,786 hours
                [[Page 61598]]
                (2 x 7,893) at an estimated cost of $1,531,242 (7,893 x 194). Thus, the
                total burden for all ESRD facilities for the policies and procedures
                requirement would be 78,930 hours (63,144 + 15,786) at an estimated
                cost of $6,140,754 ($4,609,512 + $1,531,242).
                2. Documentation and Storage
                 Section 494.30(b) also requires ESRD facilities to track and
                securely maintain the required documentation of staff COVID-19
                vaccination status. Any burden for modifying the facility's policies
                and procedures for these activities is already accounted for above. We
                believe that this would require an RN 5 minutes or 0.0833 hours to
                perform the required documentation at an adjusted hourly wage of $73
                for each employee. According to Table 3, ESRD facilities have 170,000
                employees. Hence, the burden for these documentation requirements for
                all 7,893 ESRD facilities would be 14,161 (0.0833 x 170,000) hours at
                an estimated cost of $1,033,753 (14,161 x 73).
                 Therefore, the total burden for all 7,893 ESRD facilities for this
                rule would be 93,091 (78,930 + 14,161) hours at an estimated cost of $
                7,174,507 (6,140,754 + 1,033,753).
                 The requirements and burden will be submitted to OMB under OMB
                control number 0938-0386 (expiration date March 31, 2024).
                 Based upon the above analysis, the total burden for all of the ICRs
                in this IFC is 1,555,487 hours at an estimated cost of $136,088,221.
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                BILLING CODE 4120-01-C
                 If you comment on these information collection requirements, that
                is, reporting, recordkeeping or third-party disclosure requirements,
                please submit your comments electronically as specified in the
                ADDRESSES section of this IFC.
                 Comments must be received on/by January 4, 2022.
                V. Response to Comments
                 Because of the large number of public comments we normally receive
                on Federal Register documents, we are not able to acknowledge or
                respond to them individually. We will consider all comments we receive
                by the date and time specified in the DATES section of this preamble,
                and, when we proceed with a subsequent document, we will respond to the
                comments in the preamble to that document.
                VI. Regulatory Impact Analysis
                A. Statement of Need
                 The COVID-19 pandemic has precipitated the greatest public health
                crisis in the U.S. since the 1918 Influenza pandemic. The population of
                older adults, and LTC facility residents in particular, have been hard
                hit by the impacts of the pandemic. Among those infected, the death
                rate for older adults age 65 or higher was hundreds of time higher than
                for those in their 20s during 2020.\223\ Of the approximately 656,000
                Americans estimated to have died from COVID-19 through September 10,
                2021,\224\ 30 percent are estimated to have died during or after an LTC
                facility stay, although these numbers are decreasing as vaccination
                rates increase in residents and staff as shown in the CDC Data Tracker.
                Despite the recent nation-wide surge in infections from the Delta
                variant of COVID-19, uptake of vaccines and other measures (masking,
                screening visitors, and social distancing in particular) to prevent
                COVID-19, in combination with available therapeutic options to treat,
                has reduced COVID-19-related patient deaths in all settings. But
                reductions in COVID-19-related morbidity and mortality depend
                critically on continued success in vaccination of all health care staff
                and patients. The May 13, 2021 COVID-19 IFC (86 FR 26306) required
                offering vaccination to residents and staff, but did not mandate
                vaccination. Recently, however the Departments of Defense and Veterans
                Affairs staff, and civilian Federal Government employees have become
                subject to requirements similar to those imposed in this rule.\225\
                This IFC will close a gap in current regulations for all categories of
                health care provider whose health and safety practices are directly
                regulated by CMS. Almost all CMS-regulated providers and suppliers
                disproportionately serve people who are older, disabled, chronically
                ill, or who have complex health care needs.\226\ Because the health
                care sector has such widespread and direct contact with hundreds of
                millions of patients, clients, residents, and program participants, the
                protective scope of this rule is far broader than the health care staff
                that it directly affects.
                ---------------------------------------------------------------------------
                 \223\ For updated data, see CDC daily updates of total deaths at
                https://www.cdc.gov/nchs/nvss/vsrr/COVID19/index.htm, and the Kaiser
                Family Foundation weekly updates on nursing home deaths at https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/, among other sources.
                 \224\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
                 \225\ https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5703.
                 \226\ For data on the massive differences in healthcare usage by
                age, see the National Health Expenditure Date at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet.
                ---------------------------------------------------------------------------
                B. Overall Impact
                 We have examined the impacts of this rule as required by Executive
                Order 12866 on Regulatory Planning and Review (September 30, 1993),
                Executive Order 13563 on Improving Regulation and Regulatory Review
                (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
                1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
                section 202 of the
                [[Page 61602]]
                Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4),
                Executive Order 13132 on Federalism (August 4, 1999), and the
                Congressional Review Act (5 U.S.C. 804(2)).
                 Executive Orders 12866 and 13563 direct agencies to assess all
                costs and benefits of available regulatory alternatives and, if
                regulation is necessary, to select regulatory approaches that maximize
                net benefits (including potential economic, environmental, public
                health and safety effects, distributive impacts, and equity). Section
                3(f) of Executive Order 12866 defines a ``significant regulatory
                action'' as an action that is likely to result in a rule: (1) Having an
                annual effect on the economy of $100 million or more in any 1 year, or
                adversely and materially affecting a sector of the economy,
                productivity, competition, jobs, the environment, public health or
                safety, or State, local, or tribal governments or communities (also
                referred to as ``economically significant''); (2) creating a serious
                inconsistency or otherwise interfering with an action taken or planned
                by another agency; (3) materially altering the budgetary impacts of
                entitlement grants, user fees, or loan programs or the rights and
                obligations of recipients thereof; or (4) raising novel legal or policy
                issues arising out of legal mandates, the President's priorities, or
                the principles set forth in the Executive Order.
                 A regulatory impact analysis (RIA) must be prepared for major rules
                with economically significant effects ($100 million or more in any 1
                year). We estimate that this rulemaking is ``economically significant''
                as measured by the $100 million threshold, and hence also a major rule
                under the Congressional Review Act. Accordingly, we have prepared an
                RIA that, taken together with COI section and other sections of the
                preamble, presents to the best of our ability the costs and benefits of
                the rulemaking.
                 This RIA focuses on the overall costs and benefits of the rule,
                taking into account vaccination uptake to date or anticipated over the
                next year that is not due to this rule, and estimating the likely
                additional effects of this rule on both provider staff and the patients
                with whom they come in contact. We analyze both the costs of the
                required actions and the payment of those costs. As intended under
                these requirements, this RIA's estimates cover only those costs and
                benefits that are likely to be the effects of this rule. There are also
                several unknowns that may affect current progress or this rule or both.
                These include the duration of strong vaccine protection with or without
                a booster shot and the possibility of new virus variants that reduce
                the effectiveness of currently authorized and approved vaccines. We
                cannot estimate the effects of each of the possible interactions among
                them, but throughout the analysis we point out some of the most
                important assumptions we have made and the possible effects of
                alternatives to those assumptions. The providers and suppliers
                regulated under this rule are diverse in nature, management structure,
                and size. That said, we believe that the costs faced by regulated
                entities will be very similar on a ``per person vaccinated'' basis.
                Tables 5 and 6 show the full scope of provider and supplier types,
                facility structures, and staff sizes, taking into account part-time
                staff (Table 5) and estimated staff turnover (Table 6). As explained
                earlier in the preamble, this rule includes facility contractors and
                consulting specialists as well as other persons providing part-time or
                occasional services to these providers and suppliers and their
                patients.
                 In Table 5 we provide a rough estimate of the likely number of
                full-time employees and other employees and contractors subject to this
                rule. The ``total staff'' number in the rightmost column is the number
                of individual staff directly affected at the time this rule takes
                effect (adding the number of full-time employees to the number of part-
                time employees, contractors, and other business persons who have
                recurring patient or staff interactions).
                BILLING CODE 4120-01-P
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                BILLING CODE 4120-01-C
                 This rule presents additional difficulties in estimating both costs
                and benefits due to the high degree to which all current provider and
                supplier staff
                [[Page 61604]]
                have already received information about the benefits and safety of
                COVID-19 vaccination, and the rare serious risks associated with it.
                Despite this progress, the proportion of fully vaccinated health care
                staff has approached but not hit the 70 percent with significant
                variation among states. Moreover, among the general population more
                than 600,000 persons a day are currently being vaccinated with the
                first or second shot and about 100,000 a day have recovered from
                infection and are only in very rare cases still infectious. These
                changes reduce the risk to both health care staff and patients
                substantially, likely by about 20 million persons a month who are no
                longer sources of future infections.\227\ This in turn reduces the
                number of newly infected cases (currently about 100,000 a day and
                decreasing rapidly). Yet another variable of importance is the
                increasing number of providers and suppliers that are mandating
                employee vaccination, and the increasing number of states that are
                doing so as well. To characterize the baseline scenario of no new
                regulatory action, from which we estimate the incremental impacts of
                the interim final rule, we assume that when Phase 1 of this IFC goes
                into effect, 75 percent of provider staff, 90 percent of LTC facility
                residents, and 80 percent of all other patients and clients will have
                been vaccinated, and that these rates will improve over time as a
                result of both this rule and the other factors previously
                discussed.\228\
                ---------------------------------------------------------------------------
                 \227\ These data are taken from or calculated from the CDC COVID
                Data Tracker. For example, in recent weeks the number of new daily
                cases has been gradually decreasing from about 150,000 to about
                90,000. Once the disease runs its course, almost all these people
                will have recovered. Hence, we use the rough estimate that about
                100,000 a day have recovered in recent weeks.
                 \228\ Among long term care residents, the vaccinated percentage
                is now very close to 90 percent, but other categories of patients
                are undoubtedly lower. That said, patients are heavily age-skewed
                towards higher ages where vaccination percentages are higher.
                ---------------------------------------------------------------------------
                 These numbers leave a large range for the likely effects of this
                rule over time. They do indicate, however, that many cases of death or
                severe illness can be prevented by increasing the number of vaccinated
                persons, both for those vaccinated and for others they might otherwise
                infect. As estimated in Table 6, the number of unvaccinated health care
                workers still remains in the millions despite recent progress. As
                discussed later in this analysis, we use the concept of the value per
                statistical life and per statistical case to capture this major
                potential benefit, as recommended by the Office of the Assistant
                Secretary for Planning and Evaluation based on standard practices in
                cost-benefit analysis.\229\
                ---------------------------------------------------------------------------
                 \229\ See ``Valuing COVID-19 Mortality and Morbidity Risk
                Reductions in U.S. Department of Health and Human Services
                Regulatory Impact Analyses, https://aspe.hhs.gov/reports/valuing-covid-19-risk-reductions-hhs-rias.
                ---------------------------------------------------------------------------
                 One additional factor affecting our estimates is remaining life
                expectancy. Life expectancy varies by age, being about 40 years across
                an entire population, close to 80 years for a younger population, and a
                relatively fewer number of years for an older population. These
                numbers, of course, are overall averages and mask substantial
                differences by race and sex (among other factors), including access to
                affordable health care and prevalence of untreated or insufficiently
                controlled disease. Individuals with diabetes, for example, are
                disproportionately African American and disproportionately older, which
                leads to greater risks from kidney failure and other adverse health
                effects, including greater susceptibility to the ravages of COVID-
                19.\230\ Health care staff of most types of providers and suppliers are
                of typical working ages. But hospital patients, LTC facility residents,
                ESRD patients treated for kidney failure, and most other patients are
                heavily weighted towards older ages and are disproportionately members
                of African American and Native American minority groups. This means
                that the morbidity and mortality reductions from this rule when they
                are adjusted for the age ranges affected disproportionally benefit
                racial minorities.
                ---------------------------------------------------------------------------
                 \230\ For an NIH summary of the racial disparities, see https://www.niddk.nih.gov/health-information/kidney-disease/race-ethnicity.
                ---------------------------------------------------------------------------
                 In particular, LTC facility residents are near the upper end of the
                age spectrum. For a statistically average LTC facility resident, the
                average pre-COVID-19 life expectancy if death occurs while in the
                facility is likely to be on the order of 3 years or fewer but taking
                into account residents who recover and leave the facility and those
                enrolled for skilled nursing services we estimate overall life
                expectancies to be about 5 years.\231\ We also estimate that
                vaccination reduces the chance of infection by about 95 percent, and
                the risk of death from the virus to a fraction of 1 percent.\232\ In
                Israel, of the first 2.9 million people vaccinated with two doses there
                were only about 50 infections involving severe conditions resulting
                from the virus after the 14th day and of these so few deaths that they
                were not reported in statistical summaries. These data also show that
                COVID-19 vaccines are effective for both older and younger recipients.
                Of those who have received a full primary vaccine series, after the
                14th day after vaccination only 46 people over the age of 60 became
                infected and had a severe case, compared to 6 people under the age of
                60. Given that these numbers are compared against 2.9 million
                recipients of the second dose, both rates are near zero.\233\
                ---------------------------------------------------------------------------
                 \231\ At age 80, the average life expectancy of a male is about
                8 years and of females about 10 years, or an overall average of
                about 9 years. Long term care nursing home residents, however, have
                shorter life expectancies because they have severe health problems
                or would not have been admitted to a facility. For those who remain
                in a facility until death the average life expectancy is about 2
                years. But some recover and leave so we have used 5 years as a
                reference point. See discussion at David B. Reuben, ``Medical Care
                for the Final Years of Life: When you're 83, It's not going to be 20
                years,'' JAMA, Dec. 23, 2009, 2686-2694.
                 \232\ For patients in skilled nursing facilities, average length
                of stay is less than a month. Hence, turnover is far higher.
                 \233\ See Dvir Aran, Estimating real-world COVID-19 vaccine
                effectiveness in Israel using aggregated counts, medRxiv, February
                28, 2021, at https://www.medrxiv.org/content/10.1101/2021.02.05.21251139v3.full.pdf and Noa Dagan et al, ``BNT162b2 mRNA
                Covid-19 Vaccine in a Nationwide Mass Vaccination Setting,'' The New
                England Journal of Medicine, 2/24/2021, at https://www.nejm.org/doi/full/10.1056/NEJMoa2101765.
                ---------------------------------------------------------------------------
                C. Anticipated Costs of the Interim Final Rule With Comment Period
                 We note that our cost estimates assume that all additional
                vaccination costs for providers and suppliers regulated by this rule
                are due to this rule. We estimate on this basis because we have no
                reliable way to estimate how much of these costs might be equally due
                to independent employer decisions, to other Federal standards, to State
                and local mandates, or even to individual personal choices.
                 In our cost estimates we cover all providers regulated by CMS for
                health and safety standards, but we often use LTC facilities for
                examples because they pose some of the greatest risks for COVID-19
                morbidity and mortality. As documented subsequently in this analysis
                and in a research report on this issue, about 1.5 million individuals
                work in LTC facilities at any one time.\234\ A number of these
                individuals work in multiple LTC facilities which may play additional
                roles in transmission.235 236 These individuals are at high
                risk both to become ill with COVID-19 and to transmit the SARS-
                [[Page 61605]]
                CoV-2 virus to residents or visitors, or among themselves. Far more
                than most occupations, LTC facility work requires sustained close
                contact with multiple persons daily.
                ---------------------------------------------------------------------------
                 \234\ Kaiser Family Foundation, COVID-19 and Workers at Risk:
                Examining the Long-Term Care Workforce, April 23, 2020, at https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce/.
                 \235\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267626/.
                 \236\ https://www.anderson.ucla.edu/faculty_pages/keith.chen/papers/WP_Nursing_Home_Networks_and_COVID19.pdf.
                ---------------------------------------------------------------------------
                 In Table 6 we present estimates of total numbers of staff
                individuals regulated under this rule, distinguishing between numbers
                at the beginning of a year and at any one time during the year, versus
                the much higher numbers when turnover is considered. In Table 6 we
                assume that the number departing each year is the same as the number
                entering each year, which is a reasonable approximation to changes in
                just a few years, but do not take account of the aging of the
                population over time. We note that our estimates do not include a
                deduction for the overlap among individuals who work in more than one
                LTC facility. We know that this number is substantial, but have no
                basis for estimating its precise magnitude and, more importantly, how
                it may change after this rule goes into effect and facilities change
                their staffing and hiring patterns. One recent study found about 17% of
                LTC nursing staff held second jobs, and another recent study found that
                about 5% held more than one LTC job. The second study, moreover, found
                that facilities with substantial staff sharing were disproportionally
                associated with as many as 49% of nursing home COVID-19 cases.\237\
                ---------------------------------------------------------------------------
                 \237\ See Courtney Harold Van Houtven, Nicole DePasquale, and
                Norma B. Coe, ``Essential Long-Term Care Workers Commonly Hold
                Second Jobs and Double- or Triple-Duty Caregiving Roles,'' Journal
                of the American Geriatrics Society, 27 April 2020, at https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.16509 and
                M. Keith Chen, Judith A. Chevalier, and Elisa F. Long, ``Nursing
                home staff networks and COVID-19,'' PNAS, January 5, 2021, at
                https://www.pnas.org/content/118/1/e2015455118.
                ---------------------------------------------------------------------------
                BILLING CODE 4120-01-P
                [[Page 61606]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.030
                BILLING CODE 4120-01-C
                 These figures are approximations, because none of the data that is
                routinely collected and published on resident populations or staff
                counts focus on numbers of individuals residing or working in the
                facility during the course of a year or over time. Depending on the
                average length of stay (that is, turnover) in different facilities,
                [[Page 61607]]
                an average population at any one time of, for example, 100 persons
                could be consistent with radically different numbers of individuals,
                such as 112 individuals in one facility if one person left each month
                and was replaced by another person, compared to 365 if one person left
                each day and was replaced that same day by another person.
                 As a specific example, we assume that about 90 percent of existing
                LTC facility residents and 75 percent of existing staff will have been
                vaccinated by the date Phase 1 of this IFC takes effect (we use the
                same or similar assumptions for all provider types). There will be many
                new persons in each category during the first full year of the
                regulation, and likely almost all of these will have been vaccinated
                elsewhere (for simplicity we also assume a base rate 95 percent for
                this group, almost all of whom will have previously worked in a health
                care facility requiring vaccination).
                 As presented in the third numeric column of Table 6, the total
                number of employees or otherwise compensated individuals working in all
                these different facilities over the course of a year is about 13
                million persons, which is almost half again larger than the annual
                average number of staff shown in the first numeric column. A recent
                study, using data from detailed payroll records, found that median
                turnover rates for all nurse staff in long term care facilities is
                approximately 90 percent a year, although other estimates are far lower
                (see subsequent discussion).\238\ We have not seen figures this high
                for other provider types but some may approach this level--home health
                care is well known for high turnover rates.\239\ Of course, most of
                these persons will have been vaccinated through other means when they
                enter the facilities during the next year. That said, it is likely that
                there will be approximately 2.4 million staff at the beginning or
                during the first year after this rule is published who will require
                vaccination (rightmost column of Table 6), possibly preceded in some
                cases by counseling efforts or employer inducements.
                ---------------------------------------------------------------------------
                 \238\ Ashvin Gandhi et al, ``High Nursing Staff Turnover In
                Nursing Homes Offers Important Quality Information,'' Health
                Affairs, March 2021, pages 384-391.
                 \239\ Ashvin Gandhi et al, ``High Nursing Staff Turnover In
                Nursing Homes Offers Important Quality Information,'' Health
                Affairs, March 2021, pages 384-391. Published estimates vary widely.
                For example, two recent sources said home health care staff turnover
                is about 65 percent. See https://www.hcaoa.org/newsletters/caregiver-turnover-rate-is-652-2021-home-care-benchmarking-study and
                https://www.leadingage.org/sites/default/files/Direct%20Care%20Workers%20Report%20%20FINAL%20%282%29.pdf.
                ---------------------------------------------------------------------------
                 While this IFC does not expressly require COVID-19 vaccine
                counseling or education, we anticipate that some providers and
                suppliers will conduct such activities as a part of their procedures
                for ensuring compliance with the provisions of this rule. Some staff
                counseling can take place in group settings and some will take place on
                a one-to-one level. What works best will depend on the circumstance of
                the employee and the best method for conveying the information and
                answering questions. Staff education, using CDC or FDA materials, can
                also take place in various formats and ways. Individualized counseling,
                staff meetings, posters, bulletin boards, and e-newsletters are all
                approaches that can be used. Informal education may also occur as staff
                go about their daily duties, and some who have been vaccinated may
                promote vaccination to others. Facilities may find that reward
                techniques, among other strategies, may help. For example, monetary or
                other benefits such as paid days off could be given to staff who agree
                to vaccination. Even simpler, the employer can bring vaccination
                providers onsite to vaccinate staff (or both staff and unvaccinated
                patients). Of importance in such efforts, the value of immunization as
                a crucial component of keeping patients healthy and well is already
                conveyed to staff about influenza and pneumococcal vaccines. COVID-19
                vaccine persuasion can build upon that knowledge. The most important
                inducement will be the fear of job loss, coupled with the examples set
                by fellow vaccine-hesitant workers who are accepting vaccination more
                or less simultaneously.
                 One hundred percent success is unlikely. The HHS Guidelines for
                Regulatory Impact Analysis note that ``[i]n most cases, the analysis
                focuses on estimating the incremental compliance costs incurred by the
                regulated entities, assuming full compliance with the regulation, and
                government costs.'' These guidelines further recommend that
                ``[a]nalysts should consider the uncertainty associated with an
                assumption of full compliance and provide analysis of alternative
                assumptions, as appropriate.'' \240\ In preparing this analysis, we
                have identified several significant sources of uncertainty for these
                full-compliance estimates, one of which stands out.
                ---------------------------------------------------------------------------
                 \240\ At https://aspe.hhs.gov/sites/default/files/private/pdf/242926/HHS_RIAGuidance.pdf, page 24.
                ---------------------------------------------------------------------------
                 If only one health care provider in an area required staff
                vaccination, then those who refuse vaccination could quit and obtain
                employment at another location in the same field or type of
                position.\241\ But with many employers already mandating vaccination,
                and with nearly all local (and distant) health care employers requiring
                vaccination under this rule, we expect that such effects will be
                minimized (with exceptions for medical or other exemptions as required
                by law). That said, currently there are endemic staff shortages for
                almost all categories of employees at almost all kinds of health care
                providers and supplier and these may be made worse if any substantial
                number of unvaccinated employees leave health care employment
                altogether. In this regard, we note that because CMS does not regulate
                health and safety in physician and dental offices, or in non-health
                care settings such as assisted living facilities, those entities may
                provide alternative places of employment for some of the staff
                currently working for providers and suppliers subject to this IFC who
                refuse vaccinations. On the other hand, staff shortages might be offset
                by persons returning to the labor market who were unwilling to work at
                locations where some other employees are unvaccinated and hence provide
                some risk, to those who have completed the primary vaccination series
                for COVID-19. Despite these uncertainties, we have developed an
                estimate of staffing disruption costs, primarily to provide a complete
                cost picture even if this element is particularly uncertain. We note
                that these costs and benefits are highly dependent on whether, for
                example, staff vaccination refusals in coming months are closer to 1
                percent than to 10 percent, and the extent to which increased
                confidence in the safety of working in a health care setting leads to
                offsetting increases in the return of former health care employees to
                the workforce. Both variables, in turn, may depend in significant ways
                on the overall labor market and on the ability of telehealth measures
                to replace in-person staff to patient encounters. The net outcomes of
                staff turnover over time could easily exceed or offset the
                administrative and vaccination costs we have estimated. We welcome
                comments and information on these issues.
                ---------------------------------------------------------------------------
                 \241\ See https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html, and .
                ---------------------------------------------------------------------------
                 The techniques for staff counseling, education, and incentives are
                so numerous and varied that there is no simple way to estimate likely
                costs. Staff hesitancy may and likely will change over time as the
                benefits of vaccination become clear to increasing numbers of
                individuals working in health care
                [[Page 61608]]
                settings. For purposes of estimation, we assume that, on average, one
                hour of staff time or the equivalent will be devoted to counseling or
                incentives for each unvaccinated staff person, at the same average
                hourly cost of about $75 estimated for RNs in the Information
                Collection analysis. We assume that these efforts occur during paid
                working hours and that all costs will be borne by the facility. Since
                we estimate that about 2.4 million employees will need to be vaccinated
                (or replaced) in the first year (rightmost column of Table 6), most in
                the first two months after this rule is published, total costs would be
                about $180 million. This estimate assumes that the 2.4 million will be
                some mix of existing and replacement staff. For example, if 95% of the
                existing unvaccinated staff were vaccinated, and 5% of the unvaccinated
                staff terminated, then in addition to the normal turnover of 2.7
                million new hires (second column of Table 6) an additional 114 thousand
                (.05 x 2,270) persons would need to be hired, with 95% of them already
                fully vaccinated and the remainder getting vaccinated as a condition of
                hiring. For purposes of this estimate we ignore the existence of
                exemptions.
                 A third major cost component of compliance with this IFC is the
                vaccination, including both administration and the vaccine itself. We
                estimate that the average cost of a vaccination is what the government
                pays under Medicare: $20 x 2 = $40 for two doses of a vaccine, and $20
                x 2 for vaccine administration of two doses, for a total of $80 per
                employee. For purposes of estimation (and not reflecting any more
                knowledge than recent press accounts), we further assume that there
                will be a ``booster'' shot at the same cost, for a total vaccination
                cost of $120 per employee. While these vaccine costs are currently
                incurred by the Federal Government, we include them to provide an
                estimate of total costs, regardless of who pays. In addition, we expect
                that a significant amount of time--one hour on average--will be used
                per employee in vaccine planning, arrangement, and administration, and
                related activities for three vaccinations per currently unvaccinated
                employee. Together with the additional assumption that there will be an
                hour RN time or the equivalent needed for arranging or administering
                vaccination, at an average cost for that hour of $75, the total cost
                for vaccination compliance will be $195 per employee. We apply that
                cost to all currently unvaccinated employees. Like counseling and
                incentives, if 5% of the existing unvaccinated staff leave and are
                replaced by a slightly higher number of new hires than would otherwise
                be needed, a roughly equivalent fraction of the new hires will need to
                be vaccinated before they have patient contact. As a result, we
                estimate the total costs of vaccination to be approximately $466
                million (2,390,000 unvaccinated employees x $195). We note again that
                these estimates do not reflect the factor that multiple vaccine
                mandates already do or will soon apply to many and perhaps most
                providers covered by our rule (employers' own self-imposed mandates,
                State and local mandates, and OSHA ETS, among others). This means the
                costs of this rule are overestimated due to this factor, a conservative
                assumption.
                 Our fourth and final major cost category is staffing and service
                disruptions. As discussed previously, it is possible there may be
                disruptions in cases where substantial numbers of health care staff
                refuse vaccination and are not granted exemptions and are terminated,
                with consequences for employers, employees, and patients. We do not
                have a cost estimate for those, since there are so many variables and
                unknowns, and it is unclear how they might be offset by reductions in
                current staffing disruptions caused by staff illness and quarantine
                once vaccination is more widespread. We believe, however, that the
                disruptive forces are weaker than the return to normality. As shown in
                Table 6, it is normal for there to be roughly 2.66 million new hires
                (column two) in the health care settings we address in this rule,
                compared to a baseline of roughly 10.4 million staff (column one).
                These new hires replace a roughly equal number of employees leaving for
                one reason or another. Health care providers are already in the
                business of finding and hiring replacement workers on a large scale.
                The terminated or self-terminated workers are not going to disappear.
                They still need to earn a living. Many of the non-clinical staff may
                will find employment situations in settings that are not subject to
                vaccination mandates. Cooks, for example, may migrate to restaurant
                jobs. But in those cases, a cook who would otherwise have been hired by
                a restaurant may find a newly vacant health care position requiring
                vaccination and accept (or more likely already have) vaccination.
                Similarly, nurses may find jobs in health care settings that are not
                subject to vaccination mandates, such as most schools or physician
                offices. But that means that nurses who would otherwise have been hired
                in schools or physician offices may find jobs in vacant jobs in health
                care settings requiring vaccination and accept (or more likely already
                have) vaccination. In a dynamic labor market such behaviors occur
                continuously on a massive scale. If net employment opportunities and
                job-seeking behaviors do not change (and there is no reason to believe
                they will), these continuous adjustments will leave health care
                providers and suppliers subject to this rule with their desired staff
                levels, and former employees who refused vaccination in jobs that do
                not require vaccination. Because job seeking and worker seeking are
                already operating on a massive scale in the health care sector, there
                is no reason to expect any massive new costs in such routine functions
                as advertising jobs, checking applicant employment history,
                familiarizing new employees with the nuances of the new employment
                setting, training, and all the other steps and costs involved in the
                normal workings of the labor market.
                 As an example of the likely magnitude of hiring costs, one analysis
                of direct hiring costs for workers in the long-term care sector
                (including LTC facilities, home health care, and ICFs-IID) found that
                the direct costs of hiring new workers was on average about $2,500 in
                2004.\242\ Assuming that this amount should be raised to $4,000 based
                on inflation since then, that a comparable estimate for higher skills
                health care professions would be $6,000, and that health care workers
                covered by this rule are half lower skilled and half higher skilled,
                the recruitment and hiring cost for additional hires equal to 5 percent
                of the normal annual hiring total of 2.4 million workers would be $600
                million (an average of $5,000 x 120,000). (Costs could actually be
                lower because this study is almost a decade old and internet services
                have in recent years made recruitment and job application procedures
                far easier.)
                ---------------------------------------------------------------------------
                 \242\ Dorie Seavey, The Cost of Frontline Turnover in Long-Term
                Care,'' Better Jobs Better Care Report, Washington, DC: Institute
                for the Future of Aging Services, American Association of Homes and
                Services for the Aging. 2004.
                ---------------------------------------------------------------------------
                 An additional cost category may result from COVID-19-related staff
                shortages, discussed extensively earlier in this IFC. Although, as
                noted earlier, COVID-related staff shortages are occurring absent the
                rule due to numerous factors, such as infection, quarantine and staff
                illness. Shortages at their most acute prevent facilities from
                admitting as patients, clients, residents, or participants persons they
                would normally admit for treatment of diseases or conditions that would
                in many cases result in death or serious disability. We
                [[Page 61609]]
                are not aware of any data that would enable a reasonably accurate
                estimate of the total medical morbidity and mortality involved, but it
                is certainly massive. While it is true that compliance with this rule
                may create some short-term disruption of current staffing levels for
                some providers or suppliers in some places, there is no reason to think
                that this will be a net minus even in the short term, given the
                magnitude of normal turnover and the relatively small fraction of that
                turnover that will be due to vaccination mandates. Moreover, the
                benefits of vaccination are not just the lives directly saved, but the
                resources that vaccination frees up because hospital, LTC facility, and
                rehabilitation beds are now available and because health care staff
                themselves are not being incapacitated or killed by COVID-19 infection.
                The data on cumulative COVID-19 cases among health care personnel show
                677,000 cases (most of which incapacitated workers at least
                temporarily), and 2,200 deaths, all of which permanently eliminated
                those workers as sources of future care.\243\
                ---------------------------------------------------------------------------
                 \243\ CDC Data Tracker, October 17, 2021 data, at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
                ---------------------------------------------------------------------------
                 Table 7 shows all of the costs that we have estimated. As
                previously explained, much and perhaps most of these costs would be
                incurred under other concurrent mandates, including employer-specific
                decisions, other Federal standards, and some State and local government
                mandates. Since these efforts overlap in scope, reach, and timing,
                there is no basis for assigning most of these costs to this rule or any
                other similar rule.
                [GRAPHIC] [TIFF OMITTED] TR05NO21.031
                 There are major uncertainties in these estimates. One obvious
                example is whether vaccine efficacy will last more than the
                approximately 1 year proven to date and whether boosters are
                needed.\244\ Some in the scientific community believe that ``booster''
                vaccinations after 6 or 8 months would be desirable to maintain a high
                level of protection against the predominant Delta version of the virus.
                Delta may be overtaken by other virus mutations, which creates another
                uncertainty. Booster vaccination or use of vaccines whose licenses or
                EUAs have been amended to address new variants would likely maintain
                the effectiveness of vaccination for residents and staff. At this time,
                as to second (and succeeding) year effects we assume no further major
                changes in vaccine effectiveness. Yet another uncertainty is treatment
                costs, with a recently announced antiviral pill that could potentially
                provide substantial reductions in severity of illness and subsequent
                treatment costs, on a time schedule as yet unknown.\245\
                ---------------------------------------------------------------------------
                 \244\ For a discussion of this issue, see Sumathi Reddy, ``How
                Long Do Covid-19 Vaccines Provide Immunity?'', The Wall Street
                Journal, April 13, 2021, at https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094.
                 \245\ See Rebecca Robbins, ``Merck Says It Has the First
                Antiviral Pill Found to Be Effective Against Covid,'' The New York
                Times, October 1, 2021.
                ---------------------------------------------------------------------------
                D. Anticipated Benefits of the Interim Final Rule With Comment Period
                 There will be more than 180 million staff, patients, and residents
                employed or treated each year in the facilities covered by this rule.
                In our analysis of first-year benefits of this rule we focus first on
                prevention of death among staff of facilities as well as on reduction
                in disease severity. Second, we focus on resulting benefits from
                avoiding infection by unvaccinated staff among patients served in these
                facilities, who are likely to benefit more substantially because
                patients receiving health care in such facilities are
                disproportionately older than working age adults and are therefore more
                susceptible to severe illness or death from COVID-19. A third group of
                beneficiaries are staff family members and caregivers and many other
                persons outside the health care settings who staff might subsequently
                infect if not vaccinated. We focus initially on LTC facilities because
                their residents and patients have been among the most severely affected
                by COVID-19 as well as illustrating all the estimating issues involved,
                but the same estimates, uncertainties, and calculations apply to all
                types of providers and suppliers in varying degrees.
                 HHS's Guidelines for Regulatory Impact Analysis outline a standard
                approach to valuing the health benefits of regulatory actions. The
                approach for valuing mortality risk reductions is based on the value
                per statistical life (VSL), which estimates individuals' willingness to
                pay (WTP) to avoid fatal risks. The approach to valuing morbidity risk
                reductions is based on measures of the WTP to avoid non-fatal risks
                when specific estimates are available, and based on measures of the
                duration and severity of the illness, including quality of life
                consequences, when suitable WTP estimates are not available.\246\ Based
                on this approach, the Office of the Assistant Secretary for Planning
                and Evaluation published a report that develops an approach for valuing
                COVID-19 mortality and morbidity risk reductions.
                ---------------------------------------------------------------------------
                 \246\ As noted above, various populations are directly or
                indirectly affected by this rule. Lessened risk to patients due to
                staff vaccination, especially in a setting such as a LTC facility,
                is arguably an externality (a canonical market failure), and thus
                use of a VSL or VSLY estimate per avoided fatality or life extension
                does not represent a divergence from the concept of revealed
                preference. On the other hand, staff members' own risk raises the
                question of how to interpret their hesitation or unwillingness, in
                the absence of regulation, to accept an intervention that achieves
                extensive health protection for themselves, with little or no out-
                of-pocket cost, and ever-lessening time or inconvenience cost; a
                simplistic revealed-preference monetization of the rule's effect
                would be that it yields minimal or negative benefits for such staff
                members, even the ones for whom it prevents or reduces severity of
                COVID-19 infection. However, given the dynamic nature of the
                pandemic, it may be that long-run equilibrium for COVID-19 vaccines
                has not been reached, in which case the simplistic approach just
                mentioned may be misleading--and the use of a standard VSL or VSLY
                for staff-member risk evaluation may reflect misunderstandings of
                either vaccine risks or vaccine benefits.
                ---------------------------------------------------------------------------
                [[Page 61610]]
                 In addition to the avoided death and human suffering, one of the
                major benefits of vaccination is that it lowers the cost of treating
                the disease among those who would might otherwise be infected and have
                serious morbidity consequences. The largest part of those costs is for
                hospitalization. As discussed later in the analysis we provide data on
                the average costs of hospitalization of these patients (it is, however,
                unclear as to how much that cost will change over time due to improving
                treatment options).
                 There is a potential offset to benefits that we have not estimated
                because we believe it is at this time not relevant in the U.S. If
                vaccine supplies did not meet all demands for vaccination, giving
                priority to some persons over others necessarily meant that some
                persons would become infected who would not have been infected had the
                priorities been reversed. In this case, however, the priority for older
                adults (virtually all of whom have risk factors) who comprise the
                majority of hospital inpatients and the vast majority of LTC facility
                residents has already been established and is largely met. This rule
                provides a priority for staff at a far lower risk of mortality and
                severe disease that benefits both groups.\247\ It achieves this benefit
                because by preventing the spread of COVID-19 from provider and supplier
                staff, it actually provides a higher mortality and morbidity reduction
                for patients at far higher risk than the staff who become
                vaccinated.\248\
                ---------------------------------------------------------------------------
                 \247\ The risk of death from infection from an unvaccinated 75-
                to 84-year-old person is 320 times more likely than the risk for an
                18- to 29-years old person. CDC, ``Risk for COVID-19 Infection,
                Hospitalization, and Death by Age Group'', at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html.
                 \248\ We note that as long as most of the world's population
                remains unvaccinated, another variant of the vaccine might arise and
                create new risks or shifts in risks within the U.S. That said, the
                world-wide shortage of vaccines is essentially over taking into
                account both stocks and existing manufacturing capacity and the
                biggest problem abroad is getting the available vaccines rapidly
                into the billions of people who need them.
                ---------------------------------------------------------------------------
                 The HHS ``Guidelines for Regulatory Impact Analysis'' explain in
                some detail the concept of Quality Adjusted Life Years (QALYs).\249\
                QALYs, when multiplied by a monetary estimate such as the Value of a
                Statistical Life Year (VSLY), are estimates of the value that people
                are willing to pay for life-prolonging and life-improving health care
                interventions of any kind (see sections 3.2 and 3.3 of the HHS
                Guidelines for a detailed explanation). The QALY and VSLY amounts used
                in any estimate of overall benefits are not meant to be precise, but
                instead are rough statistical measures that allow an overall estimate
                of benefits expressed in dollars.
                ---------------------------------------------------------------------------
                 \249\ https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis.
                ---------------------------------------------------------------------------
                 Under a common approach to benefit calculation, we can use a Value
                of a Statistical Life (VSL) to estimate the dollar value of the life-
                saving benefits of a policy intervention, for a person who more broadly
                represent a mixture of ages. We use the VSL of approximately $11.5
                million in 2021 as described in the HHS Guidelines, adjusted for
                changes in real income and inflated to 2020 dollars using the Consumer
                Price Index.\250\ Using LTC facilities as an example, and assuming that
                the average rate of death from COVID-19 (following SARS-CoV-2
                infection) at typical LTC facility resident ages and conditions is 5
                percent, and the average rate of death after vaccination is essentially
                zero, the expected value of each resident who would, in the absence of
                this rule, otherwise be infected with SARS-CoV-2 is about $575,000
                ($11.5 million x .05). For staff, who are generally of working ages in
                roughly the same proportions as the population at large, the typical
                rate of death for the full course of two vaccines (or possibly three
                with a booster) is roughly 1 percent of the older adult rate, and the
                expected value for each employee receiving the same vaccinations is
                about $57,500 ($11.5 million x .005).\251\ For community residents who
                unvaccinated staff might infect, the resulting calculation is similar
                (actually somewhat lower because the risk of death from COVID-19 is
                even lower for those below employment ages).
                ---------------------------------------------------------------------------
                 \250\ We note that the VSL is based on a sample of individuals
                whose average age is 40, This leads to complexities in estimates for
                populations who are much younger or older, including LTC residents.
                See Lisa Robinson and James K. Hammit, ``Valuing Reductions in Fatal
                Illness Risks: Implications of Recent Research,'' Health Economics,
                August 2016, pp. 1039-1052.
                 \251\ For the full likelihood distributions for all age ranges,
                see the CDC age distribution table previously referenced .
                ---------------------------------------------------------------------------
                 Under a second approach to benefit calculation, we can estimate the
                monetized value of extending the life of LTC facility residents, which
                is based on expectations of life expectancy and the value per life-
                year. As explained in the HHS Guidelines, the average individual in
                studies underlying the VSL estimates is approximately 40 years of age,
                allowing us to calculate a value per life-year of approximately
                $590,000 and $970,000 for 3 and 7 percent discount rates respectively.
                This estimate of a value per life-year corresponds to 1 year at perfect
                health. (These amounts might reasonably be halved for average LTC
                facility residents, since non-institutionalized U.S. adults aged 80-89
                years report average health-related quality of life (HRQL) scores of
                0.753, and this figure is likely to be lower for LTC facility
                residents.\252\) Assuming that the average life expectancy of long term
                care residents is 5 years, the monetized benefits of saving one
                statistical life would be about $3.0 million ($590,000 x annually for 5
                years) at a 3 percent discount rate and about $4.8 million ($970,000 x
                annually for 5 years) at a 7 percent discount rate. Assuming that the
                average rate of death from COVID-19 (SARS-CoV-2 infection) at LTC
                facility resident ages and conditions is 5 percent, and the average
                rate of death after vaccination is essentially zero, the expected life-
                extending value of each resident who would otherwise be infected is
                $150 thousand at a 3 percent discount rate and $240 thousand at a 7
                percent discount rate. A similar calculation can be made for staff and
                for the community residents they might infect, who will gain many more
                years of life but whose risk of death is far smaller since their age
                distribution is so much younger. Deaths from COVID-19 in unvaccinated
                LTC facility residents during 2020 were about 130,000, or close to one
                tenth of the average LTC facility resident census of 1.4 million, a
                huge contrast to the handful of deaths in the vaccination results from
                Israel.\253\ We do not have sufficient data so as to accurately
                estimate annual resident inflows and outflows over time, but it is
                clear that over two million new residents and over 700,000 new
                employees make the total number of individuals involved during the year
                far higher than point in time or average counts. Moreover, these counts
                do not include family members and other visitors, whose total visits
                certainly number in the millions.
                ---------------------------------------------------------------------------
                 \252\ Hanmer, J. W.F. Lawrence, J.P. Anderson, R.M. Kaplan, D.G.
                Fryback. 2006. ``Report of Nationally Representative Values for the
                Noninstitutionalized US Adult Population for 7 Health-Related
                Quality-of-Life Scores.'' Medical Decision Making. 26(4): 391-400.
                 \253\ Deaths are from COVID-19 Nursing Home Data, CMS, Week
                Ending 2/21/2021, at https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/.
                ---------------------------------------------------------------------------
                 Most of the preceding calculations address residential long-term
                care. Long term care residents are a major group within LTC facilities
                and are generally in the LTC facility because their needs are more
                substantial and they need assistance with the activities of daily
                living, such as cooking, bathing, and dressing. These long-term stays
                are
                [[Page 61611]]
                primarily funded by the Medicaid program (also, through long term care
                insurance or self-financed), and the custodial care services these
                residents receive are not normally covered by Medicare or any other
                health insurance.\254\ A second major group within the same facilities
                receives short-term skilled nursing care services. These services are
                rehabilitative and generally last only days, weeks, or months. They
                usually follow a hospital stay and are primarily funded by the Medicare
                program or other health insurance. The importance of these distinctions
                is that the numbers of residents and typical ages in each category
                regulated under this rule in each category are different. The average
                number of persons in facilities for long term care over the course of a
                year is about 1.2 million residents (as is the point-in-time number),
                and the total number of persons over the course of a year is about 1.6
                million. The average number in skilled nursing care at any one time is
                about 2 thousand persons, because the average length of stay is weeks
                rather than years and the median length of stay is days rather than
                weeks.\255\ The annual turnover in this group is such that about 2.3
                million residents are served each year. There is some overlap between
                these two populations and the same person may be admitted on more than
                one occasion. For purposes of this analysis (these are rough estimates
                because there are no data routinely published on patient and resident
                turnover or providing unduplicated counts of persons served), we assume
                that the expected longevity for each group is identical on average, and
                that a total of 3.9 million different persons are served each year. The
                employee staff are a third group and the direct target of these rules.
                Since both long-term and short-term residents are for the most part
                served in the same facilities, their care is managed and provided by
                the same facility staff.
                ---------------------------------------------------------------------------
                 \254\ For a discussion on this problem, see ``Medicare and You:
                at https://www.medicare.gov/medicare-and-you
                 \255\ In fact, the average length of stay for skilled nursing
                care is about 25 days. See MEDPAC, Report to the Congress: Medicare
                Payment Policy, March 2019, ``Skilled nursing facility services,''
                page 200.
                ---------------------------------------------------------------------------
                 These nursing facilities have about 950,000 full-time equivalent
                employees at any one time and another 100,000 visiting staff or the
                equivalent, all covered by this rule. For these persons, the average
                age is about 45, which creates two offsetting effects: they have more
                years of life expectancy than residents, but their risk of death from
                COVID-19 is far lower. For purposes of this analysis, we assume that
                vaccination against COVID-19 is effective for at least 1 year and use a
                1-year period as our primary framework for calculation of potential
                benefits, not as a specific prediction but as a likely scenario that
                avoids forecasting major and unexpected changes that are either
                strongly adverse or strongly beneficial. If we were adding up totals
                for benefits we would assume that the risk of death after COVID-19
                infection is likely only one-half of one percent (one tenth of the
                resident rate) or less for the unvaccinated members of this group,
                reflecting the far lower mortality rates for persons who are almost all
                in the 18 to 65 year old age ranges compared to the far older
                residents.\256\ We assume that the total number of individual employees
                is 50 percent higher than the full-time equivalent but that only half
                that number are primarily employed at only one nursing facility, two
                offsetting assumptions about the number of employees working at each
                facility (many employees are part-time consultants or the equivalent
                who serve multiple nursing facilities on a part-time basis). We further
                assume that employee turnover is 80 percent a year, lower than the
                results for nurses previously cited. Accordingly, we estimate that 80
                percent of 950,000, or 760,000, are new employees each year and must be
                offered vaccination (again, most are already vaccinated), for a total
                of 1,710,000 eligible employees over the course of a year. (This number
                would likely drop in future years as employers decide to hire only
                persons previously vaccinated and as vaccine uptake increases due to
                Federal, State, local, or employer requirements, as well as individual
                choice.)
                ---------------------------------------------------------------------------
                 \256\ See the previously cited CDC report on risks by age group.
                In the age intervals used by CDC, the 40-49-year-old group is in the
                middle of typical employment age ranges. The risk of death in this
                age group is one tenth that of those aged 65-74. We emphasize with
                round numbers that nothing about these data is fixed and unlikely to
                change (for example, as better future treatments are used to treat
                severe cases).
                ---------------------------------------------------------------------------
                 We have some data on the costs of treating serious illness among
                the unvaccinated who become infected, are hospitalized, and survive.
                Among those age 65 years or above, or with severe risk factors, over 30
                percent of those known to be infected required hospitalization in the
                first year of the pandemic.\257\ That fraction is far lower now as
                treatments have improved and as vaccinations have greatly reduced
                severity of the disease. Among adults aged 21 years to 64 years, about
                10 percent of those infected once required hospitalization, but that
                fraction is now far lower for the same reasons. For our estimates, we
                assume a 10 percent hospitalization rate among people aged 65 years or
                older in LTC facilities, reflecting both that their conditions are
                significantly worse than those of similarly aged adults living
                independently, and that pre-hospitalization treatments have improved.
                For staff we assume one fifth of this rate, or 2 percent. Using LTC
                facilities as our main example, the LTC facility candidates for
                vaccination in the first year covered by this rule, about three-fourths
                are age 65 years or above. Hence, the age-weighted hospitalization rate
                that we project is about 8 percent. Among those hospitalized at any
                age, the average cost is about $20,000.\258\
                ---------------------------------------------------------------------------
                 \257\ The New York Times ``Nearly One-Third of U.S. Coronavirus
                Deaths Are Linked to Nursing Homes, June 1, 2021.
                 \258\ This is not a robust estimate but is supported by several
                sources. See for example Jiangzhuo Chen et al, ``Medical costs of
                keeping the US economy open during COVID-19,'' Scientific Reports,
                Nature.com, July 19 2020, at https://pubmed.ncbi.nlm.nih.gov/32743613/, and Michel Kohli et al, ``The potential public health and
                economic value of a hypothetical COVID-19 vaccine in the United
                States: Use of cost-effectiveness modeling to inform vaccination
                prioritization,'' Science Direct, February 12, 2021, at https://pubmed.ncbi.nlm.nih.gov/33483216/.
                ---------------------------------------------------------------------------
                 To put these cost, benefit, and volume numbers in perspective,
                vaccinating one hundred previously unvaccinated LTC facility residents
                who would otherwise become infected with SARS-CoV-2 and have a COVID-19
                illness would cost approximately $18,000 ($183 x 100) in vaccination
                costs. Using the VSL approach to estimation would produce life-saving
                benefits of about $400,000 for these 100 people ($20,000 x 100 x .05),
                again assuming the death rate for those ill from COVID-19 of this age
                and condition is one in twenty. Reductions in health care costs from
                hospitalization would produce another $160,000 ($20,000 x 100 x .08) in
                benefits for this group assuming that 8 percent would otherwise be
                hospitalized. However, this comparison should be taken as necessarily
                hypothetical and contingent due to the analytic, data, and uncertainty
                challenges discussed throughout this regulatory impact assessment.
                Patient benefits are simply a consequence of fewer infections among
                staff. Vaccinating one hundred previously unvaccinated LTC facility
                employees would be higher than for staff. Life-saving benefits to
                employees would be about $5,300,000 ($10,600,000 VSL x 100 x .005) for
                100 people assuming that the death rate for these far younger 100
                people is 1 in 500 hundred. Reductions in health care costs from
                hospitalizations of employees would produce another $20,000 ($20,000 x
                100 x .01).
                [[Page 61612]]
                 There remain difficult questions of estimating (1) likely numbers
                of individuals in staff and patient categories who are likely to be
                unvaccinated when the rule goes into effect and (2) numbers of staff
                likely to be willing to accept vaccination in the coming months and
                years.\259\ Both sets of numbers vary substantially by provider and
                supplier type. LTC facility and home health care patients are on
                average both the oldest and most health-impaired of those in settings
                covered by this rule. At the other extreme, rural and other community-
                care oriented health centers serve the full age spectrum and a lower
                fraction of severely health-impaired.
                ---------------------------------------------------------------------------
                 \259\ For a survey of the evidence on this issue, see Gillian K.
                Steelfisher et al, ``An Uncertain Public--Encouraging Acceptance of
                Covid-19 Vaccines,'' The New England Journal of Medicine, March 3,
                2021.
                ---------------------------------------------------------------------------
                 We do know that the life-saving benefits for staff are probably
                small but significant. During the entire period of COVID-19 infections,
                since March 2020, there have been over 2,000 health care staff deaths
                recorded by the CDC through October 3, 2021.\260\ Of these, the great
                majority were in the year 2020. Even during the recent Delta variant
                surge, health care staff deaths decreased to lower levels.
                Specifically, during the last 6 months, April through September 2021,
                total staff deaths were 202, an average of 34 per month and no clear
                trend (the last 4 weeks, all in September, 2021 produced fewer than 20
                deaths). This is not surprising as the most effective precautions other
                than vaccination--masks, social distancing, and ventilation--have been
                essentially universal in the health care sector during all of 2021.
                Even more importantly, vaccination rates are considerably higher than
                in the population at large (although still well below optimal levels).
                Yet, using the last 6 months of CDC Data Tracker information, on an
                annual basis more than 400 deaths could be expected. These data,
                moreover, are almost all among unvaccinated persons and are probably
                undercounted in current data.
                ---------------------------------------------------------------------------
                 \260\ CDC Data Tracker at https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths.
                ---------------------------------------------------------------------------
                 A major caution about these estimates: None of the sources of
                enrollment information for these programs regularly collect and publish
                information on client or staff turnover during a year. These data have
                not previously been found useful in program management for individual
                agencies or programs, or when needed have been addressed through one-
                time research projects. The estimates in this analysis are based on
                inferences from scattered data on average length of stay, mortality,
                job vacancies, news accounts, and other sources that by happenstance
                are available for one type of facility or type of resident or another.
                Nor do we have data on the number of persons in these settings who will
                be vaccinated through other means during the remainder of the year.
                 All these data and estimation limitations apply to even the short-
                term impacts of this rule, and major uncertainties remain as to the
                future course of the pandemic, including but not limited to vaccine
                effectiveness in preventing ``breakthrough'' disease transmission from
                those vaccinated, the long-term effectiveness of vaccination, the
                emergence of treatment options, and the potential for some new disease
                variant even more dangerous than Delta.
                 Another unknown is what currently unvaccinated employees would do
                when the vaccination deadline is reached, and how rapidly those
                quitting rather than being vaccinated could be replaced. Even a small
                fraction of recalcitrant unvaccinated employees could disrupt facility
                operations. On the other hand, there have been significant reductions
                in provider and supplier staffing needs in some categories. For
                example, LTC facility admissions have declined in the last year, as
                families and caregivers sought to avoid the risks of exposing a care
                recipient to unvaccinated residents and staff in LTC facilities. The
                new vaccination requirement may reduce such fears and bring higher
                numbers of residents to these facilities and the essential services
                they provide. Again, we have no way to estimate such behavioral
                changes.
                 Regardless, we believe it is clear that reductions in patient/
                resident fatalities through avoiding staff-generated infections are
                both likely to be a significantly larger benefit from staff vaccination
                than direct benefits to staff. Staff vaccination will also provide
                significant community benefits when staff are not at work. Hence, total
                lives saved under this rule may well reach several hundred a month or
                perhaps several thousand a month for all three groups in total. Patient
                and resident benefits are especially likely to be many times higher
                because the risks of death and serious disease complications are so
                many times higher among older persons and people with multiple chronic
                conditions.
                 As indicated by the preceding analysis, predicting the full range
                of benefits and costs in either the short run or the next full year
                with any degree of estimating precision is all but impossible. As the
                minimum benefit level needed for benefits to exceed costs, however, we
                estimate that either saving 120 lives, or preventing 600 hundred
                hospitalizations for serious illness, or any combination of these two
                magnitudes, would produce benefits that exceed our estimate of costs
                over the next year. There have been about 200 staff deaths in the last
                6 months and this is a likely undercount for this one category of
                persons alone, and potential life-saving benefits to more than 150
                million mostly elderly patients and residents (about 10 percent of whom
                are likely to remain unvaccinated) who are exposed to provider staff
                probably would be many times higher. We note, however, as discussed in
                the preceding section on costs, much of these benefits could be as well
                attributed to other concurrent and parallel vaccination mandates and
                campaigns.
                E. Other Effects
                1. Sources of Payment
                 The initial costs of this rule fall almost entirely on health care
                providers and suppliers and are extremely small in comparison to the $4
                trillion a year spent on health care, mostly through these same
                entities. In particular, the costs of the vaccines are paid by the
                Federal Government and vaccine costs are about two-thirds of the total
                costs we have estimated. Moreover, through the treatment cost savings
                to the hospitals and other care providers resulting from the
                vaccinations that will be made due to this rule, significant savings
                would accrue to payers. It is likely that half or more of these savings
                would primarily accrue to Medicare given the age or disability status
                of most clients and Medicare's role as primary payer, but there would
                also be substantial savings to Medicaid, private insurance paid by
                employers and employees, and private out-of-pocket payers including
                patients and residents. In some rare cases funds under the CARES Act
                and the American Rescue Plan Act of 2021 might be available at State or
                local discretion, but it is hard to foresee any substantial budgetary
                impact on any insurance plan or service provider that would justify or
                require such assistance.
                2. Regulatory Flexibility Act
                 The RFA requires agencies to analyze options for regulatory relief
                of small entities, if a rule has a significant impact on a substantial
                number of small entities. Under the RFA, ``small entities'' include
                small businesses, nonprofit organizations, and small governmental
                jurisdictions. Individuals and states are not included in the
                definition of a small entity. For
                [[Page 61613]]
                purposes of the RFA, we estimate that most health care facilities are
                small entities as that term is used in the RFA because they are either
                nonprofit organizations or meet the SBA definition of a small business
                (having revenues of less than $8.0 million to $41.5 million in any 1
                year). HHS uses an increase in costs or decrease in revenues of more
                than 3 to 5 percent as its measure of ``significant economic impact.''
                The HHS standard for ``substantial number'' is 5 percent or more of
                those that will be significantly impacted, but never fewer than 20.
                 As estimated previously, the total costs of this rule for 1 year
                are about $1.3 billion, most of which is directly proportional to
                number of employees. Spread over 10.4 million full-time equivalent
                employees, this is about $125 per employee. Assuming a fully loaded
                average wage per employee of $90,000, the first-year cost does not
                approach the 3 percent threshold. Moreover, since much of these costs
                (in particular, the vaccine costs paid by the Federal Government) will
                not fall on providers or suppliers, the financial strain on these
                facilities should be negligible. Finally, as previously discussed,
                there are other concurrent mandates and much of these costs could as
                well be attributed to those efforts. Therefore, the Department has
                determined that this IFC will not have a significant economic impact on
                a substantial number of small entities and that a final RIA is not
                required. Finally, this IFC was not preceded by a general notice of
                proposed rulemaking and the RFA requirement for a final regulatory
                flexibility analysis does not apply to final rules not preceded by a
                proposed rule. Regardless, this RIA and the main preamble, taken
                together, would meet the requirements for either an Initial or Final
                Regulatory Flexibility Analysis.
                3. Small Rural Hospitals
                 Section 1102(b) of the Act requires us to prepare an RIA if a
                proposed rule may have a significant impact on the operations of a
                substantial number of small rural hospitals. For purposes of this
                requirement, we define a small rural hospital as a hospital that is
                located outside of a metropolitan statistical area and has fewer than
                100 beds. Because this rule has only the small impact per employee
                calculated for RFA purposes, the Department has determined that this
                IFC will not have a significant impact on the operations of a
                substantial number of small rural hospitals. This IFC is also exempt
                because that provision of law only applies to final rules for which a
                proposed rule was published. That said, early indications are that
                rural hospitals are having greater problems with employee vaccination
                refusals than urban hospitals, and we welcome comments on ways to
                ameliorate this problem.
                4. Unfunded Mandates Reform Act
                 Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
                requires that agencies assess anticipated costs and benefits before
                issuing any rule whose mandates will impose spending costs on State,
                local, or tribal governments, or by the private sector, require
                spending in any 1 year of $100 million in 1995 dollars, updated
                annually for inflation. In 2021, that threshold is approximately $158
                million. This rule contains no State, local, or tribal governmental
                mandates, but does contain mandates on private sector entities that
                exceed this amount. However, this IFC was not preceded by a notice of
                proposed rulemaking, and therefore the requirements of UMRA do not
                apply. The analysis in this RIA and the preamble as a whole would,
                however, meet the requirements of UMRA.
                5. Federalism
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it promulgates a proposed rule (and subsequent
                final rule) that imposes substantial direct requirement costs on State
                and local governments, preempts State law, or otherwise has Federalism
                implications. This rule would pre-empt some State laws that prohibit
                employers from requiring their employees to be vaccinated for COVID-19.
                Consistent with the Executive Order, we find that State and local laws
                that forbid employers in the State or locality from imposing vaccine
                requirements on employees directly conflict with this exercise of our
                statutory health and safety authority to require vaccinations for staff
                of the providers and suppliers subject to this rule. Similarly, to the
                extent that State-run facilities that receive Medicare and Medicaid
                funding are prohibited by State or local law from imposing vaccine
                mandates on their employees, there is direct conflict between the
                provisions of this rule (requiring such mandates) and the State or
                local law (forbidding them). As is relevant here, this IFC preempts the
                applicability of any State or local law providing for exemptions to the
                extent such law provides broader grounds for exemptions than provided
                for by Federal law and are inconsistent with this IFC. In these cases,
                consistent with the Supremacy Clause of the Constitution, the agency
                intends that this rule preempts State and local laws to the extent the
                State and local laws conflict with this rule. The agency has considered
                other alternatives (for example, relying entirely on measures such as
                voluntary vaccination, source control alone, and social distancing) and
                has concluded that the mandate established by this rule is the minimum
                regulatory action necessary to achieve the objectives of the statute.
                Given the contagion rates of the existing strains of coronavirus and
                their disproportionate impacts on Medicare and Medicaid beneficiaries,
                we believe that vaccination of almost all staff of covered providers
                and suppliers is necessary to promote and protect patient health and
                safety. The agency has examined case studies from other employers and
                concludes that vaccine mandates are vastly more effective than other
                measures at achieving ideal vaccination rates and the resulting patient
                protections from morbidity and mortality. Given the emergency situation
                with respect to the Delta variant detailed more fully above, time did
                not permit usual consultation procedures with the States, and such
                consultation would therefore be impracticable. We are, however,
                inviting State and local comments on the substance as well as legal
                issues presented by this rule, and on how we can fulfill the statutory
                requirements for health and safety protections of patients if we were
                to exempt any providers or suppliers based on State or local opposition
                to this rule.
                F. Alternatives Considered
                 As discussed earlier in the preamble, a major substantive
                alternative that we considered was to limit COVID-19 vaccination
                requirements to full-time employees rather than to all persons who may
                provide paid or unpaid services, such as visiting specialists or
                volunteers, who are not on the regular payroll on a weekly or more
                frequent basis that is, individuals who work in the facility and in
                some cases infrequently or unpredictably, as well as individuals who
                are not on the payroll at all. We concluded that covering these persons
                would be readily manageable without creating major issues for
                compliance, enforcement, and record-keeping. We did not, however,
                include some categories of visitors who do not have a business
                relationship with the provider, such as family member visitors. There
                are also many issues such as social isolation and loneliness related to
                potential discouragement of visiting volunteers or family members.
                [[Page 61614]]
                 We also considered whether it would be appropriate to limit COVID-
                19 vaccination requirements to staff who have not previously been
                infected by SARS-CoV-2. There remain many uncertainties about as to the
                strength and length of this immunity compared to people who are
                vaccinated, and--in recognizing that--the CDC recommends that
                previously infected individuals get vaccinated. Exempting previously
                infected individuals would have potentially reduced benefits while
                reducing costs, both roughly in proportion to the number affected. It
                would have also, complicated administration and likely require
                standards that do not now exist for reliably measuring the declining
                levels of antibodies over time in relation to risk of reinfection.
                Because of current CDC guidance and understanding of relevant
                scientific findings, we found that it was not warranted to exempt
                previously infected individuals.
                 Another option would be to devise a standard with graduated
                compliance expectations such as 90 percent and then 95 percent and then
                100 percent of staff vaccinated and a time period in which to reach
                each level. A variation of this would be to put providers on a
                probationary period if they failed to reach 100 percent compliance by
                the date set in the rule, and were allowed additional time in which to
                cross that last threshold. Yet another variation would be to reduce
                payment to providers and suppliers not meeting the standard after the
                initial deadline. We recently put a phased system in place for Organ
                Procurement Organizations (OPOs), so we are not reflexively opposed to
                such options.\261\ Nonetheless, there are two major arguments against
                such a system in the context of this rule. First, to have any
                usefulness the time periods would have to have a reasonably extensive
                duration, such as a month each. But that would be almost the same as
                extending this rule's deadline for an extra several months. We do not
                believe that extending the deadline to extend the employment of staff
                who will simply delay vaccination or final refusal to the last possible
                moment is in the interest of other staff, patients, and patients who
                would utilize the provider for needed health care if they did not fear
                unvaccinated staff. Second, it would not only delay the achievement of
                both staff and patient safety, but encourage procrastination. For those
                few staff absolutely unwilling to accept vaccination, it would simply
                delay the day of final action and the day of hiring a vaccinated
                replacement. In the case of the OPO rule, an entire organization had to
                be slowly reformed to achieve compliance. In the context of this rule,
                and the lives at stake, there is no obvious ethical or managerial
                reason to give a relative handful of vaccination-resisting individuals
                more time until they leave the organization. It would give management
                more time to find replacements, but it is not at all clear that this
                would be a fruitful grace period.
                ---------------------------------------------------------------------------
                 \261\ See Medicare and Medicaid Programs: Organ Procurement
                Organizations Conditions for Coverage: Revisions to the Outcome
                Measure Requirements for Organ Procurement Organizations, 85 FR page
                77898, December 2, 2020.
                ---------------------------------------------------------------------------
                 As for a variation reducing payment to non-performing providers,
                perhaps by 20 percent per patient over some applicable time period,
                this would arguably provide something better than an ``all of nothing''
                removal from provider status. It would require legislation but that is
                not a barrier to meeting E.O. 12866 analysis standards and in some
                rules may be essential to a valid benefit-cost analysis. The problem
                with this variation, however, is that for most providers and suppliers
                is it unlikely to be a realistic choice. Rather than accept lower
                payment levels, management can simply terminate the unvaccinated
                employees, a power they have with or without the reduced payment
                alternative. Moreover, it would be hard to devise a system that treated
                equally and fairly providers of all sizes--whether with 5 or 50
                employees. We further note that CMS already has and uses discretion in
                enforcement when inspectors find a violation. Termination of provider
                status is not normally an immediate consequence, as entities are
                typically given the opportunity to correct deficiencies. Regardless, we
                welcome comments on this overall option and its variations, and on the
                closely-related option of simply adding a month to the compliance
                deadline in this rule. We considered what standards to apply regarding
                proof of compliance with exemptions requests base on medical
                contraindications and religious objections. We decided to establish
                minimal compliance burdens for both categories of exemptions. This
                decision on the evidentiary standards could be revisited should an
                abuse problem arise on a significant scale. This may open the door to
                forged documents or false statements, and therefore validation of such
                claims raises administrative costs. Accordingly, we have allowed for
                relatively relaxed standards for verification in our administrative
                provisions and cost estimates but may reconsider in the future. We
                considered alternative timelines for implementation but decided that
                this would not only delay badly needed live-saving compliance, but also
                provide little real management benefit to providers and suppliers.
                Staff have had almost a year to consider COVID-19 vaccinations that are
                in their own interests as well as vital to patient protections and the
                protection of other workers. In this regard we note that one of the
                claimed barriers to vaccination has recently been removed, now that one
                vaccine is now no longer emergency-authorized, but fully licensed. We
                believe our requirements provide more than enough time for reasonable
                counselling and other management measures.
                 Finally, we considered requiring daily or weekly testing of
                unvaccinated individuals. We have reviewed scientific evidence on
                testing and found that vaccination is a more effective infection
                control measure. As such, we chose not to require such testing for now
                but welcome comment. Of course, nothing prevents a provider from
                exercising testing precautions voluntarily in addition to vaccination.
                We note that nothing in this rule removes the obligation on providers
                and suppliers to meet existing requirements to prevent the spread of
                infection, which in practice means that these entities may also conduct
                regular testing alongside such actions as source control and physical
                distancing. CMS will continue to review the evidence and stakeholder
                feedback on this issue.
                 These and some lesser options are presented and discussed in the
                main preamble. We do not have reliable dollar estimates for either
                costs or benefits of any alternatives, for the reasons already
                discussed in the RIA regarding the options we chose. We welcome
                comments on these or other options.
                G. Accounting Statement and Table
                 The Accounting Table summarizes the quantified impact of this rule.
                It covers only 1 year because there will likely be many developments
                regarding treatments and vaccinations and their effects in future years
                and we have no way of knowing which will most likely occur. A longer
                period would be even more speculative than the current estimates.
                Nonetheless, assuming no major unforeseen events that would impinge on
                our estimates, we would expect lower costs in future years if for no
                other reason than increases in the fraction of new hires already
                vaccinated as well as other positive results from the President's plan
                or individual vaccination decisions. We further note
                [[Page 61615]]
                that the vaccinations, and hence the benefits and costs, estimated for
                this rule are more or less simultaneously being created voluntarily by
                some employers (self-mandates), through the OSHA vaccination rule
                applicable to employers of 100 or more persons, and by some State or
                local mandates. There is no simple and non-arbitrary way to disentangle
                which vaccination benefits and which vaccination costs are due to which
                source.
                 As explained in various places within this RIA and the preamble as
                a whole, there are major uncertainties as to the effects of current
                variants of SARS-CoV-2 on future infection rates, medical costs, and
                prevention of major illness or mortality. For example, the duration of
                vaccine effectiveness in preventing COVID-19, reducing disease
                severity, reducing the risk of death, and the effectiveness of the
                vaccine to prevent disease transmission by those vaccinated are not
                currently known. These uncertainties also impinge on benefits
                estimates. For those reasons we have not quantified into annual totals
                either the life-extending or medical cost-reducing benefits of this
                rule and have used only a 1-year projection for the cost estimates in
                our Accounting Statement (our first-year estimates are for the last two
                months of 2021 and the first ten months of 2022). We also show a large
                range for the upper and lower bounds of potential costs to emphasize
                the uncertainty as to several major variables, such as changes in
                voluntary vaccination levels, longer term effects, and others
                previously discussed. We welcome comments on all of our assumptions and
                welcome any additional information that would narrow the ranges of
                uncertainty or guide us in any important revisions to the requirements
                established in what is an ``interim'' final rule.
                [GRAPHIC] [TIFF OMITTED] TR05NO21.032
                 In accordance with the provisions of Executive Order 12866, this
                regulation was reviewed by the Office of Management and Budget.
                 Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
                Medicaid Services, approved this document on October 19, 2021.
                List of Subjects
                42 CFR Part 416
                 Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 418
                 Health facilities, Hospice care, Medicare, Reporting and
                recordkeeping requirements.
                42 CFR Part 441
                 Aged, Family planning, Grant programs--health, Infants and
                children, Medicaid, Penalties, Reporting and recordkeeping
                requirements.
                42 CFR Part 460
                 Aged, Citizenship and naturalization, Civil rights, Health, Health
                care, Health records, Incorporation by reference, Individuals with
                disabilities, Medicaid, Medicare, Religious discrimination, Reporting
                and recordkeeping requirements.
                42 CFR Part 482
                 Grant program---health, Hospitals, Medicaid, Medicare, Reporting
                and recordkeeping requirements.
                42 CFR Part 483
                 Grant programs--health, Health facilities, Health professions,
                Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
                and recordkeeping requirements, Safety.
                42 CFR Part 484
                 Administrative practice and procedure, Grant programs--health,
                Health facilities, Health professions, Medicare, Reporting and
                recordkeeping requirements.
                [[Page 61616]]
                42 CFR Part 485
                 Grant programs--health, Health facilities, Medicaid, Privacy,
                Reporting and recordkeeping requirements.
                42 CFR Part 486
                 Administrative practice and procedure, Grant programs--health,
                Health facilities, Home infusion therapy, Medicare, Reporting and
                recordkeeping requirements, X-rays.
                42 CFR Part 491
                 Grant programs--health, Health facilities, Medicaid, Medicare,
                Reporting and recordkeeping requirements, Rural and urban areas.
                42 CFR Part 494
                 Diseases, Health facilities, Incorporation by reference, Medicare,
                Reporting and recordkeeping requirements.
                 For the reasons set forth in the preamble, the Centers for Medicare
                & Medicaid Services amends 42 CFR chapter IV as set forth below:
                PART 416--AMBULATORY SURGICAL SERVICES
                0
                1. The authority citation for part 416 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                2. Amend Sec. 416.51 by adding paragraph (c) to read as follows:
                Sec. 416.51 Conditions for coverage--Infection control.
                * * * * *
                 (c) Standard: COVID-19 vaccination of staff. The ASC must develop
                and implement policies and procedures to ensure that all staff are
                fully vaccinated for COVID-19. For purposes of this section, staff are
                considered fully vaccinated if it has been 2 weeks or more since they
                completed a primary vaccination series for COVID-19. The completion of
                a primary vaccination series for COVID-19 is defined here as the
                administration of a single-dose vaccine, or the administration of all
                required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following center staff, who
                provide any care, treatment, or other services for the center and/or
                its patients:
                 (i) Center employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the center and/or its patients, under contract or by other arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following center staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the center setting and who do not have any direct
                contact with patients and other staff specified in paragraph (c)(1) of
                this section; and
                 (ii) Staff who provide support services for the center that are
                performed exclusively outside of the center setting and who do not have
                any direct contact with patients and other staff specified in paragraph
                (c)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (c)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine, prior to staff providing any
                care, treatment, or other services for the center and/or its patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (c)(1) of this section are fully vaccinated, except for those staff who
                have been granted exemptions to the vaccination requirements of this
                section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (c)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the center has
                granted, an exemption from the staff COVID-19 vaccination requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains:
                 (A) All information specifying which of the authorized or licensed
                COVID-19 vaccines are clinically contraindicated for the staff member
                to receive and the recognized clinical reasons for the
                contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the center's COVID-19
                vaccination requirements based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 418--HOSPICE CARE
                0
                3. The authority citation for part 418 continues to read as follow:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                4. Amend Sec. 418.60 by adding paragraph (d) to read as follows:
                Sec. 418.60 Condition of participation: Infection control.
                * * * * *
                 (d) Standard: COVID-19 Vaccination of facility staff. The hospice
                must develop and implement policies and procedures to ensure that all
                staff are fully vaccinated for COVID-19. For purposes of this section,
                staff are considered fully vaccinated if it has been 2 weeks or more
                since they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                [[Page 61617]]
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following hospice staff, who
                provide any care, treatment, or other services for the hospice and/or
                its patients:
                 (i) Hospice employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the hospice and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following hospice staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the settings where hospice services are provided to
                patients and who do not have any direct contact with patients, patient
                families and caregivers, and other staff specified in paragraph (d)(1)
                of this section; and
                 (ii) Staff who provide support services for the hospice that are
                performed exclusively outside of the settings where hospice services
                are provided to patients and who do not have any direct contact with
                patients, patient families and caregivers, and other staff specified in
                paragraph (d)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (d)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the hospice and/or its patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (d)(1) of this section are fully vaccinated, except for those staff who
                have been granted exemptions to the vaccination requirements of this
                section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (d)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the hospice
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains:
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the hospice's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
                SERVICES
                0
                5. The authority citation for part 441 continues to read as follows:
                 Authority: 42 U.S.C. 1302.
                0
                6. Amend Sec. 441.151 by adding paragraph (c) to read as follows:
                Sec. 441.151 General requirements.
                * * * * *
                 (c) COVID-19 Vaccination of facility staff. The facility must
                develop and implement policies and procedures to ensure that all staff
                are fully vaccinated for COVID-19. For purposes of this section, staff
                are considered fully vaccinated if it has been 2 weeks or more since
                they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or resident contact, the
                policies and procedures must apply to the following facility staff, who
                provide any care, treatment, or other services for the facility and/or
                its residents:
                 (i) Facility employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the facility and/or its residents, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following facility staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the facility setting and who do not have any direct
                contact with residents and other staff specified in paragraph (c)(1) of
                this section; and
                 (ii) Staff who provide support services for the facility that are
                performed exclusively outside of the center setting and who do not have
                any direct contact with residents and other staff specified in
                paragraph (c)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (c)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the facility and/or its
                residents;
                 (ii) A process for ensuring that all staff specified in paragraph
                (c)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been
                [[Page 61618]]
                granted exemptions to the vaccination requirements of this section, or
                those staff for whom COVID-19 vaccination must be temporarily delayed,
                as recommended by the CDC, due to clinical precautions and
                considerations;
                 (iii) A process for ensuring that the facility follows nationally
                recognized infection prevention and control guidelines intended to
                mitigate the transmission and spread of COVID-19, and which must
                include the implementation of additional precautions for all staff who
                are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (c)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains:
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the facility's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
                0
                7. The authority citation for part 460 continues to read as follow:
                 Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).
                0
                8. Amend Sec. 460.74 by adding paragraph (d) to read as follows:
                Sec. 460.74 Infection control.
                * * * * *
                 (d) COVID-19 Vaccination of PACE organization staff. The PACE
                organization must develop and implement policies and procedures to
                ensure that all staff are fully vaccinated for COVID-19. For purposes
                of this section, staff are considered fully vaccinated if it has been 2
                weeks or more since they completed a primary vaccination series for
                COVID-19. The completion of a primary vaccination series for COVID-19
                is defined here as the administration of a single-dose vaccine, or the
                administration of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or participant contact,
                the policies and procedures must apply to the following PACE
                organization staff, who provide any care, treatment, or other services
                for the PACE organization and/or its participants:
                 (i) PACE organization employees;
                 (ii) Licensed practitioners providing services on behalf of the
                PACE organization;
                 (iii) Students, trainees, and volunteers providing services on
                behalf of the PACE organization; and
                 (iv) Individuals who provide care, treatment, or other services on
                behalf of the PACE organization, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following PACE organization staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services for the PACE organization and/or its participants and who do
                not have any direct contact with participants and other PACE
                organization staff specified in paragraph (d)(1) of this section; and
                 (ii) Staff who provide support services for the PACE organization
                and/or its participants and who do not have any direct contact with
                participants and other PACE organization staff specified in paragraph
                (d)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (d)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the PACE organization and/or its
                participants;
                 (ii) A process for ensuring that all staff specified in paragraph
                (d)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (d)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the PACE
                organization has granted, an exemption from the staff COVID-19
                vaccination requirements based on recognized clinical contraindications
                or applicable Federal laws;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as
                [[Page 61619]]
                defined by, and in accordance with, all applicable State and local
                laws, and for further ensuring that such documentation contains:
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the PACE organization's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
                0
                9. The authority citation for part 482 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise
                noted.
                0
                10. Amend Sec. 482.42 by adding paragraph (g) to read as follows:
                Sec. 482.42 Condition of participation: Infection prevention and
                control and antibiotic stewardship programs.
                * * * * *
                 (g) Standard: COVID-19 Vaccination of hospital staff. The hospital
                must develop and implement policies and procedures to ensure that all
                staff are fully vaccinated for COVID-19. For purposes of this section,
                staff are considered fully vaccinated if it has been 2 weeks or more
                since they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following hospital staff, who
                provide any care, treatment, or other services for the hospital and/or
                its patients:
                 (i) Hospital employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the hospital and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following hospital staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the hospital setting and who do not have any direct
                contact with patients and other staff specified in paragraph (g)(1) of
                this section; and
                 (ii) Staff who provide support services for the hospital that are
                performed exclusively outside of the hospital setting and who do not
                have any direct contact with patients and other staff specified in
                paragraph (g)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (g)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the hospital and/or its
                patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (g)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (g)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the hospital
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains:
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the hospital's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-.
                PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
                0
                11. The authority citation for part 483 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
                0
                12. Amend Sec. 483.80 by revising paragraph (d)(3)(v) and adding
                paragraph (i) to read as follows:
                Sec. 483.80 Infection control.
                 (d) * * *
                 (3) * * *
                 (v) The resident or resident representative, has the opportunity to
                accept or refuse a COVID-19 vaccine, and change their decision; and
                * * * * *
                [[Page 61620]]
                 (i) COVID-19 Vaccination of facility staff. The facility must
                develop and implement policies and procedures to ensure that all staff
                are fully vaccinated for COVID-19. For purposes of this section, staff
                are considered fully vaccinated if it has been 2 weeks or more since
                they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or resident contact, the
                policies and procedures must apply to the following facility staff, who
                provide any care, treatment, or other services for the facility and/or
                its residents:
                 (i) Facility employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the facility and/or its residents, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following facility staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the facility setting and who do not have any direct
                contact with residents and other staff specified in paragraph (i)(1) of
                this section; and
                 (ii) Staff who provide support services for the facility that are
                performed exclusively outside of the facility setting and who do not
                have any direct contact with residents and other staff specified in
                paragraph (i)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (i)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the facility and/or its
                residents;
                 (ii) A process for ensuring that all staff specified in paragraph
                (i)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (i)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains:
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the facility's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                0
                13. Amend Sec. 483.430 by revising paragraph (f) to read as follows:
                Sec. 483.430 Condition of participation: Facility staffing.
                * * * * *
                 (f) Standard: COVID-19 Vaccination of facility staff. The facility
                must develop and implement policies and procedures to ensure that all
                staff are fully vaccinated for COVID-19. For purposes of this section,
                staff are considered fully vaccinated if it has been 2 weeks or more
                since they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or client contact, the
                policies and procedures must apply to the following facility staff, who
                provide any care, treatment, or other services for the facility and/or
                its clients:
                 (i) Facility employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the facility and/or its clients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following facility staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the facility setting and who do not have any direct
                contact with clients and other staff specified in paragraph (f)(1) of
                this section; and
                 (ii) Staff who provide support services for the facility that are
                performed exclusively outside of the facility setting and who do not
                have any direct contact with clients and other staff specified in
                paragraph (f)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (f)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care,
                [[Page 61621]]
                treatment, or other services for the facility and/or its clients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (f)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (f)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the facility's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                0
                14. Amend Sec. 483.460 by revising paragraph (a)(4)(v) to read as
                follows:
                Sec. 483.460 Condition of participation: Health care services.
                * * * * *
                 (a) * * *
                 (4) * * *
                 (v) The client, or client's representative, has the opportunity to
                accept or refuse a COVID-19 vaccine, and change their decision;
                * * * * *
                PART 484--HOME HEALTH SERVICES
                0
                15. The authority citation for part 484 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395hh.
                0
                16. Amend Sec. 484.70 by adding paragraph (d) to read as follows:
                Sec. 484.70 Condition of participation: Infection prevention and
                control.
                * * * * *
                 (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The
                home health agency (HHA) must develop and implement policies and
                procedures to ensure that all staff are fully vaccinated for COVID-19.
                For purposes of this section, staff are considered fully vaccinated if
                it has been 2 weeks or more since they completed a primary vaccination
                series for COVID-19. The completion of a primary vaccination series for
                COVID-19 is defined here as the administration of a single-dose
                vaccine, or the administration of all required doses of a multi-dose
                vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following HHA staff, who
                provide any care, treatment, or other services for the HHA and/or its
                patients:
                 (i) HHA employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the HHA and/or its patients, under contract or by other arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following HHA staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the settings where home health services are
                directly provided to patients and who do not have any direct contact
                with patients, families, and caregivers, and other staff specified in
                paragraph (d)(1) of this section; and
                 (ii) Staff who provide support services for the HHA that are
                performed exclusively outside of the settings where home health
                services are directly provided to patients and who do not have any
                direct contact with patients, families, and caregivers, and other staff
                specified in paragraph (d)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (d)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the HHA and/or its patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (d)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (d)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the HHA has
                granted, an exemption from the staff COVID-19 vaccination requirements;
                [[Page 61622]]
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the HHA's COVID-19 vaccination
                requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
                0
                17. The authority citation for part 485 continues to read as follows:
                 Authority: 42 U.S.C. 1302 and 1395(hh).
                0
                18. Amend Sec. 485.58 by revising paragraph (d)(4) to read as follows:
                Sec. 485.58 Condition of participation: Comprehensive rehabilitation
                program.
                * * * * *
                 (d) * * *
                 (4) The services must be furnished by personnel that meet the
                qualifications of Sec. 485.70 and the number of qualified personnel
                must be adequate for the volume and diversity of services offered.
                Personnel that do not meet the qualifications specified in Sec.
                485.70(a) through (m) may be used by the facility in assisting
                qualified staff. When a qualified individual is assisted by these
                personnel, the qualified individual must be on the premises, and must
                instruct these personnel in appropriate patient care service techniques
                and retain responsibility for their activities.
                * * * * *
                0
                19. Amend Sec. 485.70 by adding paragraph (n) to read as follows:
                Sec. 485.70 Personnel qualifications.
                * * * * *
                 (n) The CORF must develop and implement policies and procedures to
                ensure that all staff are fully vaccinated for COVID-19. For purposes
                of this section, staff are considered fully vaccinated if it has been 2
                weeks or more since they completed a primary vaccination series for
                COVID-19. The completion of a primary vaccination series for COVID-19
                is defined here as the administration of a single-dose vaccine, or the
                administration of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following facility staff, who
                provide any care, treatment, or other services for the facility and/or
                its patients:
                 (i) Facility employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the facility and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following facility staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the facility setting and who do not have any direct
                contact with patients and other staff specified in paragraph (n)(1) of
                this section; and
                 (ii) Staff who provide support services for the facility that are
                performed exclusively outside of the facility setting and who do not
                have any direct contact with patients and other staff specified in
                paragraph (n)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (n)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the facility and/or its
                patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (n)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (n)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the facility's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions
                [[Page 61623]]
                and considerations, including, but not limited to, individuals with
                acute illness secondary to COVID-19, and individuals who received
                monoclonal antibodies or convalescent plasma for COVID-19 treatment;
                and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                0
                20. Amend Sec. 485.640 by adding paragraph (f) to read as follows:
                Sec. 485.640 Condition of participation: Infection prevention and
                control and antibiotic stewardship programs.
                * * * * *
                 (f) Standard: COVID-19 Vaccination of CAH staff. The CAH must
                develop and implement policies and procedures to ensure that all staff
                are fully vaccinated for COVID-19. For purposes of this section, staff
                are considered fully vaccinated if it has been 2 weeks or more since
                they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following CAH staff, who
                provide any care, treatment, or other services for the CAH and/or its
                patients:
                 (i) CAH employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the CAH and/or its patients, under contract or by other arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following CAH staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the CAH setting and who do not have any direct
                contact with patients and other staff specified in paragraph (f)(1) of
                this section; and
                 (ii) Staff who provide support services for the CAH that are
                performed exclusively outside of the CAH setting and who do not have
                any direct contact with patients and other staff specified in paragraph
                (f)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (f)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the CAH and/or its patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (f)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status of all staff specified in paragraph (f)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the CAH has
                granted, an exemption from the staff COVID-19 vaccination requirements
                based on recognized clinical contraindications or applicable Federal
                laws;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the CAH's COVID-19 vaccination
                requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                0
                21. Amend Sec. 485.725 by adding paragraph (f) to read as follows:
                Sec. 485.725 Condition of participation: Infection control.
                * * * * *
                 (f) Standard: COVID-19 vaccination of organization staff. The
                organization that provides outpatient physical therapy must develop and
                implement policies and procedures to ensure that all staff are fully
                vaccinated for COVID-19. For purposes of this section, staff are
                considered fully vaccinated if it has been 2 weeks or more since they
                completed a primary vaccination series for COVID-19. The completion of
                a primary vaccination series for COVID-19 is defined here as the
                administration of a single-dose vaccine, or the administration of all
                required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following organization staff,
                who provide any care, treatment, or other services for the organization
                and/or its patients:
                 (i) Organization employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the organization and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following organization staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the organization setting and who do not have any
                direct contact with patients and other staff specified in paragraph
                (f)(1) of this section; and
                 (ii) Staff who provide support services for the organization that
                are performed exclusively outside of the organization setting and who
                do not have any direct contact with patients and other staff
                [[Page 61624]]
                specified in paragraph (f)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (f)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the organization and/or its
                patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (f)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status for all staff specified in paragraph (f)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the
                organization has granted, an exemption from the staff COVID-19
                vaccination requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the organization's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                0
                22. Amend Sec. 485.904 by adding paragraph (c) to read as follows:
                Sec. 485.904 Condition of participation: Personnel qualifications.
                * * * * *
                 (c) Standard: COVID-19 vaccination of center staff. The CMHC must
                develop and implement policies and procedures to ensure that all center
                staff are fully vaccinated for COVID-19. For purposes of this section,
                staff are considered fully vaccinated if it has been 2 weeks or more
                since they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or client contact, the
                policies and procedures must apply to the following center staff, who
                provide any care, treatment, or other services for the center and/or
                its clients:
                 (i) Center employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the center and/or its clients, under contract or by other arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following center staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the center setting and who do not have any direct
                contact with clients and other staff specified in paragraph (c)(1) of
                this section; and
                 (ii) Staff who provide support services for the center that are
                performed exclusively outside of the center setting and who do not have
                any direct contact with clients and other staff specified in paragraph
                (c)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (c)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the CMHC and/or its clients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (c)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status for all staff specified in paragraph (c)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the CMHC has
                granted, an exemption from the staff COVID-19 vaccination requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions
                [[Page 61625]]
                from vaccination, has been signed and dated by a licensed practitioner,
                who is not the individual requesting the exemption, and who is acting
                within their respective scope of practice as defined by, and in
                accordance with, all applicable State and local laws, and for further
                ensuring that such documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the CMHC's COVID-19 vaccination
                requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
                BY SUPPLIERS
                0
                23. The authority citation for part 486 continues to read as follows:
                 Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.
                0
                24. Amend Sec. 486.525 by adding paragraph (c) to read as follows:
                Sec. 486.525 Required services.
                * * * * *
                 (c) COVID-19 Vaccination of facility staff. The qualified home
                infusion therapy supplier must develop and implement policies and
                procedures to ensure that all staff are fully vaccinated for COVID-19.
                For purposes of this section, staff are considered fully vaccinated if
                it has been 2 weeks or more since they completed a primary vaccination
                series for COVID-19. The completion of a primary vaccination series for
                COVID-19 is defined here as the administration of a single-dose
                vaccine, or the administration of all required doses of a multi-dose
                vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following qualified home
                infusion therapy supplier staff, who provide any care, treatment, or
                other services for the qualified home infusion therapy supplier and/or
                its patients:
                 (i) Qualified home infusion therapy supplier employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the qualified home infusion therapy supplier and/or its patients, under
                contract or by other arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following qualified home infusion therapy supplier staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the settings where home infusion therapy services
                are provided to patients and who do not have any direct contact with
                patients, families, and caregivers, and other staff specified in
                paragraph (c)(1) of this section; and
                 (ii) Staff who provide support services for the qualified home
                infusion therapy supplier that are performed exclusively outside of the
                settings where home infusion therapy services are provided to patients
                and who do not have any direct contact with patients, families, and
                caregivers, and other staff specified in paragraph (c)(1) of this
                section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (c)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the qualified home infusion
                therapy supplier and/or its patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (c)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring that the facility follows nationally
                recognized infection prevention and control guidelines intended to
                mitigate the transmission and spread of COVID-19, and which must
                include the implementation of additional precautions for all staff who
                are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status for all staff specified in paragraph (c)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the qualified
                home infusion therapy supplier has granted, an exemption from the staff
                COVID-19 vaccination requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains;
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the qualified home infusion
                therapy supplier's COVID-19 vaccination requirements for staff based on
                the recognized clinical contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                [[Page 61626]]
                PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
                0
                25. The authority citation for part 491 continues to read as follows:
                 Authority: 42 U.S.C. 263a and 1302.
                0
                26. Amend Sec. 491.8 by adding paragraph (d) to read as follows:
                Sec. 491.8 Staffing and staff responsibilities.
                * * * * *
                 (d) COVID-19 vaccination of staff. The RHC/FQHC must develop and
                implement policies and procedures to ensure that all staff are fully
                vaccinated for COVID-19. For purposes of this section, staff are
                considered fully vaccinated if it has been 2 weeks or more since they
                completed a primary vaccination series for COVID-19. The completion of
                a primary vaccination series for COVID-19 is defined here as the
                administration of a single-dose vaccine, or the administration of all
                required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following clinic or center
                staff, who provide any care, treatment, or other services for the
                clinic or center and/or its patients:
                 (i) RHC/FQHC employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the clinic or center and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following clinic or center staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the clinic or center setting and who do not have
                any direct contact with patients and other staff specified in paragraph
                (d)(1) of this section; and
                 (ii) Staff who provide support services for the clinic or center
                that are performed exclusively outside of the clinic or center setting
                and who do not have any direct contact with patients and other staff
                specified in paragraph (d)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (d)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the clinic or center and/or its
                patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (d)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring that the clinic or center follows
                nationally recognized infection prevention and control guidelines
                intended to mitigate the transmission and spread of COVID-19, and which
                must include the implementation of additional precautions for all staff
                who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status for all staff specified in paragraph (d)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains;
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the clinic's or center's COVID-
                19 vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
                FACILITIES
                0
                27. The authority citation for part 494 continues to read as follows:
                 Authority: 42 U.S.C. l302 and l395hh.
                0
                28. Amend Sec. 494.30 by--
                0
                a. Redesignating paragraphs (b) and (c) as paragraphs (c) and (d)
                respectively, and
                0
                b. Adding a new paragraph (b).
                 The addition reads as follows:
                Sec. 494.30 Condition: Infection control.
                * * * * *
                 (b) COVID-19 Vaccination of facility staff. The facility must
                develop and implement policies and procedures to ensure that all staff
                are fully vaccinated for COVID-19. For purposes of this section, staff
                are considered fully vaccinated if it has been 2 weeks or more since
                they completed a primary vaccination series for COVID-19. The
                completion of a primary vaccination series for COVID-19 is defined here
                as the administration of a single-dose vaccine, or the administration
                of all required doses of a multi-dose vaccine.
                 (1) Regardless of clinical responsibility or patient contact, the
                policies and procedures must apply to the following facility staff, who
                provide any care, treatment, or other services for the facility and/or
                its patients:
                 (i) Facility employees;
                 (ii) Licensed practitioners;
                 (iii) Students, trainees, and volunteers; and
                 (iv) Individuals who provide care, treatment, or other services for
                the facility and/or its patients, under contract or by other
                arrangement.
                 (2) The policies and procedures of this section do not apply to the
                following facility staff:
                 (i) Staff who exclusively provide telehealth or telemedicine
                services outside of the facility setting and who do not have any direct
                contact with
                [[Page 61627]]
                patients and other staff specified in paragraph (b)(1) of this section;
                and
                 (ii) Staff who provide support services for the facility that are
                performed exclusively outside of the facility setting and who do not
                have any direct contact with patients and other staff specified in
                paragraph (b)(1) of this section.
                 (3) The policies and procedures must include, at a minimum, the
                following components:
                 (i) A process for ensuring all staff specified in paragraph (b)(1)
                of this section (except for those staff who have pending requests for,
                or who have been granted, exemptions to the vaccination requirements of
                this section, or those staff for whom COVID-19 vaccination must be
                temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations) have received, at a minimum, a single-
                dose COVID-19 vaccine, or the first dose of the primary vaccination
                series for a multi-dose COVID-19 vaccine prior to staff providing any
                care, treatment, or other services for the facility and/or its
                patients;
                 (ii) A process for ensuring that all staff specified in paragraph
                (b)(1) of this section are fully vaccinated for COVID-19, except for
                those staff who have been granted exemptions to the vaccination
                requirements of this section, or those staff for whom COVID-19
                vaccination must be temporarily delayed, as recommended by the CDC, due
                to clinical precautions and considerations;
                 (iii) A process for ensuring the implementation of additional
                precautions, intended to mitigate the transmission and spread of COVID-
                19, for all staff who are not fully vaccinated for COVID-19;
                 (iv) A process for tracking and securely documenting the COVID-19
                vaccination status for all staff specified in paragraph (b)(1) of this
                section;
                 (v) A process for tracking and securely documenting the COVID-19
                vaccination status of any staff who have obtained any booster doses as
                recommended by the CDC;
                 (vi) A process by which staff may request an exemption from the
                staff COVID-19 vaccination requirements based on an applicable Federal
                law;
                 (vii) A process for tracking and securely documenting information
                provided by those staff who have requested, and for whom the facility
                has granted, an exemption from the staff COVID-19 vaccination
                requirements;
                 (viii) A process for ensuring that all documentation, which
                confirms recognized clinical contraindications to COVID-19 vaccines and
                which supports staff requests for medical exemptions from vaccination,
                has been signed and dated by a licensed practitioner, who is not the
                individual requesting the exemption, and who is acting within their
                respective scope of practice as defined by, and in accordance with, all
                applicable State and local laws, and for further ensuring that such
                documentation contains
                 (A) All information specifying which of the authorized COVID-19
                vaccines are clinically contraindicated for the staff member to receive
                and the recognized clinical reasons for the contraindications; and
                 (B) A statement by the authenticating practitioner recommending
                that the staff member be exempted from the facility's COVID-19
                vaccination requirements for staff based on the recognized clinical
                contraindications;
                 (ix) A process for ensuring the tracking and secure documentation
                of the vaccination status of staff for whom COVID-19 vaccination must
                be temporarily delayed, as recommended by the CDC, due to clinical
                precautions and considerations, including, but not limited to,
                individuals with acute illness secondary to COVID-19, and individuals
                who received monoclonal antibodies or convalescent plasma for COVID-19
                treatment; and
                 (x) Contingency plans for staff who are not fully vaccinated for
                COVID-19.
                * * * * *
                Xavier Becerra,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2021-23831 Filed 11-4-21; 8:45 am]
                BILLING CODE 4120-01-P
                

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