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federal register vol 86 no 212 friday november 5 2021 rules and regulations 61555 authority 33 u s c 941 29 u s c 653 29 u s c 653 ...

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                                 Federal Register/Vol. 86, No. 212/Friday, November 5, 2021/Rules and Regulations                                                          61555 
                 Authority: 33 U.S.C. 941; 29 U.S.C. 653,              (29 U.S.C. 653, 655, 657); Secretary of Labor’s          DATES: 
               655, 657; Secretary of Labor’s Order No. 12–            Order No. 12–71 (36 FR 8754), 8–76 (41 FR                   Effective date: These regulations are 
               71 (36 FR 8754), 8–76 (41 FR 25059), 9–83               25059), 9–83 (48 FR 35736), 1–90 (55 FR                  effective on November 5, 2021. 
               (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62              9033), 6–96 (62 FR 111), 3–2000 (65 FR                      Implementation dates: The 
               FR 111), 3–2000 (65 FR 50017), 5–2002 (67               50017), 5–2002 (67 FR 65008), 4–2010 (75 FR              regulations included in Phase 1 [42 CFR 
               FR 65008), 5–2007 (72 FR 31160), 4–2010 (75             55355), or 8–2020 (85 FR 58393), as                      416.51(c) through (c)(3)(i) and (c)(3)(iii) 
               FR 55355), 1–2012 (77 FR 3912), or 8–2020               applicable; and 29 CFR 1911.                             through (x), 418.60(d) through (d)(3)(i) 
               (85 FR 58393), as applicable; and 29 CFR                   Section 1928.21 also issued under 49                  and (d)(3)(iii) through (x), 441.151(c) 
               1911.                                                   U.S.C. 1801–1819 and 5 U.S.C. 553. 
                 Sections 1918.90 and 1918.110 also issued                                                                      through (c)(3)(i) and (c)(3)(iii) through 
               under 5 U.S.C. 553.                                     Subpart B—Applicability of Standards                     (x), 460.74(d) through (d)(3)(i) and 
                 Section 1918.100 also issued under 49                                                                          (d)(3)(iii) through (x), 482.42(g) through 
               U.S.C. 5101 et seq. and 5 U.S.C. 553.                   ■ 16. Amend §1928.21 by adding                           (g)(3)(i) and (g)(3)(iii) through (x), 
               ■ 12. Add subpart K to part 1918 to read                paragraph (a)(8) to read as follows:                     483.80(d)(3)(v) and 483.80(i) through 
               as follows:                                             §1928.21 Applicable standards in 29 CFR                  (i)(3)(i) and (i)(3)(iii) through (x), 
                                                                       part 1910.                                               483.430(f) through (f)(3)(i) and (f)(3)(iii) 
               Subpart K—COVID–19.                                        (a) * * *                                             through (x), 483.460(a)(4)(v), 484.70(d) 
               Sec.                                                       (8) COVID–19—§1910.501, but only                      through (d)(3)(i) and (d)(3)(iii) through 
               1918.107–1918.109 [Reserved]                            with respect to—                                         (x), 485.58(d)(4), 485.70(n) through 
               1918.110 COVID–19.                                         (i) Agricultural establishments where                 (n)(3)(i) and (n)(3)(iii) through (x), 
               1918.107 through 1918.109 [Reserved]                    eleven (11) or more employees are                        485.640(f) through (f)(3)(i) and (f)(3)(iii) 
                                                                       engaged on any given day in hand-labor                   through (x), 485.725(f) through (f)(3)(i) 
               §1918.110 COVID–19.                                     operations in the field; and                             through (f)(3)(iii) through (x), 485.904(c) 
                  The requirements applicable to                          (ii) Agricultural establishments that                 through (c)(3)(i) and (c)(3)(iii) through 
               longshoring work under this section are                 maintain a temporary labor camp,                         (x), 486.525(c) through (c)(3)(i) and 
               identical to those set forth at 29 CFR                  regardless of how many employees are                     (c)(3)(iii) through (x), 491.8(d) through 
               1910.501.                                               engaged on any given day in hand-labor                   (d)(3)(i) and (d)(3)(iii) through (x), 
               PART 1926—SAFETY AND HEALTH                             operations in the field.                                 494.30(b) through (b)((3)(i) and (b)(3)(iii) 
               REGULATIONS FOR CONSTRUCTION                            * * * * *                                                through (x) must be implemented by 
                                                                       [FR Doc. 2021–23643 Filed 11–4–21; 8:45 am]              December 6, 2021. 
               ■ 13. The authority citation for part                   BILLING CODE 4510–26–P                                      The regulations included in Phase 2 
               1926 is revised to read as follows:                                                                              [42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii), 
                                                                                                                                441.151(c)(3)(ii), 460.74(d)(3)(ii), 
                 Authority: 40 U.S.C. 3704; 29 U.S.C. 653,             DEPARTMENT OF HEALTH AND                                 482.42(g)(3)(ii), 483.80(i)(3)(ii), 
               655, and 657; and Secretary of Labor’s Order            HUMAN SERVICES                                           483.430(f)(3)(ii), 484.70(d)(3)(ii), 
               No. 12–71 (36 FR 8754), 8–76 (41 FR 25059),                                                                      485.70(n)(3)(ii), 485.640(f)(3)(ii), 
               9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–               Centers for Medicare & Medicaid                          485.725(f)(3)(ii), 485.904(c)(3)(ii), 
               96 (62 FR 111), 3–2000 (65 FR 50017), 5–                Services                                                 486.525(c)(3)(ii), 491.8(d)(3)(ii), 
               2002 (67 FR 65008), 5–2007 (72 FR 31159),                                                                        494.30(b)(3)(ii)] must be implemented 
               4–2010 (75 FR 55355), 1–2012 (77 FR 3912),              42 CFR Parts 416, 418, 441, 460, 482,                    by January 4, 2022. Staff who have 
               or 8–2020 (85 FR 58393), as applicable; and             483, 484, 485, 486, 491 and 494 
               29 CFR part 1911.                                                                                                completed a primary vaccination series 
                 Sections 1926.58, 1926.59, 1926.60, and               [CMS–3415–IFC]                                           by this date are considered to have met 
               1926.65 also issued under 5 U.S.C. 553 and                                                                       these requirements, even if they have 
               29 CFR part 1911.                                       RIN 0938–AU75                                            not yet completed the 14-day waiting 
                 Section 1926.61 also issued under 49                                                                           period required for full vaccination. 
               U.S.C. 1801–1819 and 5 U.S.C. 553.                      Medicare and Medicaid Programs;                             Comment date: To be assured 
                 Section 1926.62 also issued under sec.                Omnibus COVID–19 Health Care Staff                       consideration, comments must be 
               1031, Public Law 102–550, 106 Stat. 3672 (42            Vaccination                                              received at one of the addresses 
               U.S.C. 4853).                                                                                                    provided below, no later than 5 p.m. on 
                 Section 1926.65 also issued under sec. 126,           AGENCY: Centers for Medicare & 
               Public Law 99–499, 100 Stat. 1614 (reprinted            Medicaid Services (CMS), HHS.                            January 4, 2022. 
               at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.              ACTION: Interim final rule with comment  ADDRESSES: In commenting, please refer 
               Subpart D—Occupational Health and                       period.                                                  to file code CMS–3415–IFC. 
               Environmental Controls                                                                                              Comments, including mass comment 
                                                                       SUMMARY: This interim final rule with                    submissions, must be submitted in one 
               ■ 14. Add §1926.58 to read as follows:                  comment period revises the                               of the following three ways (please 
                                                                       requirements that most Medicare- and                     choose only one of the ways listed): 
               §1926.58 COVID–19.                                      Medicaid-certified providers and                            1. Electronically. You may submit 
                  The requirements applicable to                       suppliers must meet to participate in the  electronic comments on this regulation 
               construction work under this section are  Medicare and Medicaid programs.                                        to http://www.regulations.gov. Follow 
               identical to those set forth at 29 CFR                  These changes are necessary to help                      the ‘‘Submit a comment’’ instructions. 
               1910.501 Subpart U.                                     protect the health and safety of                            2. By regular mail. You may mail 
                                                                       residents, clients, patients, PACE                       written comments to the following 
               PART 1928—OCCUPATIONAL SAFETY  participants, and staff, and reflect                                              address ONLY: Centers for Medicare & 
               AND HEALTH STANDARDS FOR                                lessons learned to date as a result of the               Medicaid Services, Department of 
               AGRICULTURE                                             COVID–19 public health emergency.                        Health and Human Services, Attention: 
                                                                       The revisions to the requirements                        CMS–3415–IFC, P.O. Box 8016, 
               ■ 15. The authority citation for part                   establish COVID–19 vaccination                           Baltimore, MD 21244–8016. 
               1928 is revised to read as follows:                     requirements for staff at the included                      Please allow sufficient time for mailed 
                 Authority: Sections 4, 6, and 8 of the                Medicare- and Medicaid-certified                         comments to be received before the 
               Occupational Safety and Health Act of 1970              providers and suppliers.                                 close of the comment period. 
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               61556             Federal Register/Vol. 86, No. 212/Friday, November 5, 2021/Rules and Regulations 
                  3. By express or overnight mail. You                 • Ambulatory Surgical Centers (ASCs)                     Occupational Safety and Health 
               may send written comments to the                           (§416.51)                                             Administration (OSHA) for certain 
               following address ONLY: Centers for                     • Hospices (§418.60)                                     employers. 
               Medicare & Medicaid Services,                           • Psychiatric residential treatment                         Currently, the United States (U.S.) is 
               Department of Health and Human                             facilities (PRTFs) (§441.151)                         responding to a public health 
               Services, Attention: CMS–3415–IFC,                      • Programs of All-Inclusive Care for the                 emergency (PHE) of respiratory disease 
               Mail Stop C4–26–05, 7500 Security                          Elderly (PACE) (§460.74)                              caused by a novel coronavirus that has 
               Boulevard, Baltimore, MD 21244–1850.                    • Hospitals (acute care hospitals,                       now been detected in more than 190 
                  For information on viewing public                       psychiatric hospitals, hospital swing                 countries internationally, all 50 States, 
               comments, see the beginning of the                         beds, long term care hospitals,                       the District of Columbia, and all U.S. 
               SUPPLEMENTARYINFORMATION section.                          children’s hospitals, transplant                      territories. The virus has been named 
               FORFURTHERINFORMATIONCONTACT:                              centers, cancer hospitals, and                        ‘‘severe acute respiratory syndrome 
                  For press inquiries: CMS Office of                      rehabilitation hospitals/inpatient                    coronavirus 2’’ (SARS–CoV–2), and the 
               Communications, Department of Health                       rehabilitation facilities) (§482.42)                  disease it causes has been named 
               and Human Services; email press@                        • Long Term Care (LTC) Facilities,                       ‘‘coronavirus disease 2019’’ (COVID– 
               cms.hhs.gov.                                               including Skilled Nursing Facilities                  19). On January 30, 2020, the 
                  For technical inquiries: Contact CMS                    (SNFs) and Nursing Facilities (NFs),                  International Health Regulations 
               Center for Clinical Standards and                          generally referred to as nursing homes  Emergency Committee of the World 
               Quality, Department of Health and                          (§483.80)                                             Health Organization (WHO) declared 
               Human Services, (410) 786–6633.                         • Intermediate Care Facilities for                       the outbreak a ‘‘Public Health 
                                                                          Individuals with Intellectual                         Emergency of International Concern.’’ 
               SUPPLEMENTARYINFORMATION:                                  Disabilities (ICFs–IID) (§483.430)                    On January 31, 2020, pursuant to 
                  Inspection of Public Comments: All                   • Home Health Agencies (HHAs)                            section 319 of the Public Health Service 
               comments received before the close of                      (§484.70)                                             Act (PHSA) (42 U.S.C. 247d), the 
               the comment period are available for                    • Comprehensive Outpatient                               Secretary of the Department of Health 
               viewing by the public, including any                       Rehabilitation Facilities (CORFs)                     and Human Services (Secretary) 
               personally identifiable or confidential                    (§§485.58 and 485.70)                                 determined that a PHE exists for the 
               business information that is included in                • Critical Access Hospitals (CAHs)                       U.S. (hereafter referred to as the PHE for 
               a comment. We post all comments                            (§485.640)                                            COVID–19). On March 11, 2020, the 
               received before the close of the                        • Clinics, rehabilitation agencies, and                  WHO publicly declared COVID–19 a 
               comment period on the following                            public health agencies as providers of                pandemic. On March 13, 2020, the 
               website as soon as possible after they                     outpatient physical therapy and                       President of the United States declared 
               have been received: http://                                speech-language pathology services                    the COVID–19 pandemic a national 
               www.regulations.gov. Follow the search                     (§485.725)                                            emergency. The January 31, 2020 
               instructions on that website to view                    • Community Mental Health Centers                        determination that a PHE for COVID–19 
               public comments. CMS will not post on                      (CMHCs) (§485.904)                                    exists and has existed since January 27, 
               Regulations.gov public comments that                    • Home Infusion Therapy (HIT)                            2020, lasted for 90 days, and was 
               make threats to individuals or                             suppliers (§486.525)                                  renewed on April 21, 2020; July 23, 
               institutions or suggest that the                        • Rural Health Clinics (RHCs)/Federally  2020; October 2, 2020; January 7, 2021; 
               individual will take actions to harm the                   Qualified Health Centers (FQHCs)                      April 15, 2021; July 19, 2021; and 
               individual. CMS continues to encourage                     (§491.8)                                              October 18, 2021. Pursuant to section 
               individuals not to submit duplicative                   • End-Stage Renal Disease (ESRD)                         319 of the PHSA, the determination that 
               comments. We will post acceptable                          Facilities (§494.30)                                  a PHE continues to exist may be 
               comments from multiple unique                              This IFC directly applies only to the                 renewed at the end of each 90-day 
                                                                                                                                         1
               commenters even if the content is                       Medicare- and Medicaid-certified                         period.  
               identical or nearly identical to other                  providers and suppliers listed above. It                   COVID–19 has had significant 
               comments.                                               does not directly apply to other health                  negative health effects—on individuals, 
               I. Background                                           care entities, such as physician offices,                communities, and the nation as a whole. 
                                                                       that are not regulated by CMS. Most                      Consequences for individuals who have 
                  The Centers for Medicare & Medicaid                  states have separate licensing                           COVID–19 include morbidity, 
               Services (CMS) establishes health and                   requirements for health care staff and                   hospitalization, mortality, and post- 
               safety standards, known as the                          health care providers that would be                      COVID conditions (also known as long 
               Conditions of Participation, Conditions                 applicable to physician office staff and                 COVID). As of mid-October 2021, over 
               for Coverage, or Requirements for                       other staff in small health care entities                44 million COVID–19 cases, 3 million 
               Participation for 21 types of providers                 that are not subject to vaccination                      new COVID–19 related hospitalizations, 
               and suppliers, ranging from hospitals to                requirements under this IFC. We have                     and 720,000 COVID–19 deaths have 
               hospices and rural health clinics to long               not included requirements for Organ                      been reported in the U.S.2 Indeed, 
               term care facilities (including skilled                 Procurement Organizations or Portable                    COVID–19 has overtaken the 1918 
               nursing facilities and nursing facilities,              X-Ray suppliers, as these only provide                   influenza pandemic as the deadliest 
               collectively known as nursing homes).                   services under contract to other health                                                       3
                                                                                                                                disease in American history.  
               Most of these providers and suppliers                   care entities and would thus be 
               are regulated by this interim final rule                indirectly subject to the vaccination                      1https://www.phe.gov/emergency/events/ 
               with comment period (IFC).                              requirements of this rule, as discussed                  COVID19/Pages/2019-Public-Health-and-Medical- 
               Specifically, this IFC directly regulates               in section II.A.1. of this rule. We note                 Emergency-Declarations-and-Waivers.aspx. 
               the following providers and suppliers,                  that entities not covered by this rule                     2https://covid.cdc.gov/covid-data- 
               listed in the numerical order of the                    may still be subject to other State or                   tracker#datatracker-home. 
               relevant CFR sections being revised in                  Federal COVID–19 vaccination                               3https://www.statnews.com/2021/09/20/covid- 
                                                                       requirements, such as those issued by                    19-set-to-overtake-1918-spanish-flu-as-deadliest- 
               this rule:                                                                                                       disease-in-american-history. 
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                                 Federal Register/Vol. 86, No. 212/Friday, November 5, 2021/Rules and Regulations                                                          61557 
                  Given recent estimates of                            estimated reduction for Black and                        attributed to healthcare-associated 
                                                                                                                                                 19
               undiagnosed infections and under-                       Latino populations is 3–4 times the                      transmission.        In outbreaks reported 
               reported deaths, these figures likely                   estimate for the White population,                       from acute care settings in the U.S. 
               underestimate the full impact.4 In                      reversing over 10 years of progress in                   following implementation of universal 
               addition, these figures fail to capture the  reducing the gaps in life expectancy                                masking, unmasked exposures to other 
               significant, detrimental effects of post-               between Black and White populations                      health care workers were frequently 
                                                                                                                                               20
               acute illness, including nervous system                 and reducing the Latino mortality                        implicated.       A retrospective cohort 
               and neurocognitive disorders,                           advantage by over 70 percent. The study  study of health care staff behaviors, 
               cardiovascular disorders,                               further expects that reductions in life                  exposures, and cases between June and 
               gastrointestinal disorders, and signs and               expectancy may persist because of                        December 2020 in a large health system 
               symptoms related to poor general well-                  continued COVID–19 mortality and                         found more employees were exposed 
               being, including malaise, fatigue,                      term health, social, and economic                        via coworkers than patients—and 
               musculoskeletal pain, and reduced                                                        7                       secondary cases among employees 
                                                                       impacts of the pandemic. Because 
               quality of life. Recent estimates suggest               SARS–CoV–2, the virus that causes                        typically followed unmasked 
               more than half of COVID–19 survivors                    COVID–19 disease, is highly                              interactions with infected colleagues 
               experienced post-acute sequelae of                      transmissible,8 Centers for Disease                      (for example, convening in breakrooms 
                                                             5                                                                                                           21
               COVID–19 6 months after recovery.                       Control and Prevention (CDC) has                         without proper source control).             The 
               The individual and public health                        recommended, and CMS reiterated, that                    same study found that cases of health 
               ramifications of COVID–19 also extend                   health care providers and suppliers                      care worker infection associated with 
               beyond the direct effects of COVID–19                   implement robust infection prevention                    patient exposures could often be 
               infections. Several studies have                        and control practices, including source                  attributed to failure to adhere to PPE 
               demonstrated significant mortality                      control measures, physical distancing,                   requirements (for example, eye 
               increases in 2020, beyond those                         universal use of personal protective                     protection). Past experience with 
               attributable to COVID–19 deaths. In                     equipment (PPE), SARS–CoV–2 testing,                     influenza, and available evidence, 
               some percentage, this could be a                        environmental controls, and patient                      suggest that vaccination of health care 
               problem of misattribution (for example,                                                9101112                   staff offers a critical layer of protection 
                                                                       isolation or quarantine.                 Available  against healthcare-associated COVID–19 
               the cause of death was indicated as                     evidence suggests these infection                        (HA–COVID–19). For example, evidence 
               ‘‘heart disease’’ but in fact the true cause  prevention and control practices have                              has shown that influenza vaccination of 
               was undiagnosed COVID–19), but some                     been highly effective when                               health care staff is associated with 
               proportion are also believed to reflect                 implemented correctly and                                declines in nosocomial influenza in 
               increases in other causes of death that                 consistently.1314 
                                                                                                                                                            222324
               are sensitive to decreased access to care                  Studies have also shown, however,                     hospitalized patients,              and among 
                                                                                                                                                               25262728293031
               and/or increased mental/emotional                       that consistent adherence to                             nursing home residents.                            
               strain. One paper quantifies the net                    recommended infection prevention and 
               impact (direct and indirect effects) of                 control practices can prove                                19https://www.medrxiv.org/content/10.1101/ 
               the pandemic on the U.S. population                     challenging—and those lapses can place  2021.02.16.21251625v1. 
                                                                                                                                  20https://jamanetwork.com/journals/jama/full
               during 2020 using three metrics: excess                 patients in jeopardy.15161718 A                          article/2773128. 
               deaths, life expectancy, and total years                retrospective analysis from England                        21https://www.ncbi.nlm.nih.gov/pmc/articles/ 
               of life lost. The findings indicate there               found up to 1 in 6 SARS–CoV–2                            PMC8349432/. 
               were 375,235 excess deaths, with 83                     infections among hospitalized patients                     22Weinstock DM, Eagan J, Malak SA, et al. 
               percent attributable to direct, and 17                  with COVID–19 in England during the                      Control of influenza A on a bone marrow transplant 
               percent attributable to indirect effects of             first 6 months of the pandemic could be                  unit. Infect Control Hosp Epidemiol. 2000; 21:730– 
                                                                                                                                732. 
               COVID–19. The decrease in life                                                                                     23Salgado CD, Giannetta ET, Hayden FG, Farr 
               expectancy was 1.67 years, translating                    7Andrasfay, T., & Goldman, N. (2021).                  BM. Preventing nosocomial influenza by improving 
               to a reversion of 14 years in historical                Reductions in 2020 US life expectancy due to             the vaccine acceptance rate of clinicians. Infect 
               life expectancy gains. Total years of life              COVID–19 and the disproportionate impact on the          Control Hosp Epidemiol 2004; 25:923–928. 
                                                                       Black and Latino populations. Proceedings of the           24https://pubmed.ncbi.nlm.nih.gov/31384750/. 
               lost in 2020 was 7,362,555 across the                   National Academy of Sciences of the United States          25Hayward AC, Harling R, Wetten S, et al. 
               U.S. (73 percent directly attributable, 27              of America, 118(5), e2014746118. https://doi.org/        Effectiveness of an influenza vaccine programme for 
               percent indirectly attributable to                      10.1073/pnas.2014746118 Accessed 10/17/2021.             care home staff to prevent death, morbidity, and 
               COVID–19), with considerable                              8https://www.npr.org/sections/goatsandsoda/            health service use among residents: cluster 
               heterogeneity at the individual State                   2021/08/11/1026190062/covid-delta-variant-               randomised controlled trial. BMJ 2006; 333: 1241– 
                                                                       transmission-cdc-chickenpox.                             1246. 
                      6                                                  9                                                        26Potter J, Stott DJ, Roberts MA, et al. Influenza 
               level.                                                      https://www.cdc.gov/coronavirus/2019-ncov/ 
                  One analysis published in February                   hcp/infection-control-recommendations.html.              vaccination of healthcare workers in long-term-care 
               2021 found that Black and Latino                          10https://www.cms.gov/files/document/qso-21-           hospitals reduces the mortality of elderly patients. 
               Americans have experienced a                            08-nltc.pdf.                                             J Infect Dis. 1997; 175:1–6. 
                                                                         11https://www.cms.gov/files/document/qso-21-             27Thomas RE, Jefferson TO, Demicheli V, et al. 
               disproportionate burden of COVID–19                     07-psych-hospital-prtf-icf-iid.pdf.                      Influenza vaccination for health-care workers who 
               morbidity and mortality, reflecting                       12https://www.cms.gov/files/document/qso-20-           work with elderly people in institutions: a 
               persistent structural inequalities that                 38-nh-revised.pdf.                                       systematic review. Lancet Infect Dis. 2006; 6:273– 
               increase risk of exposure to COVID–19                     13https://jamanetwork.com/journals/jamanet             279. 
                                                                                                                                  28Van den Dool C, Bonten MJM, Hak E, Heijne 
               and mortality risk for those infected.                  workopen/fullarticle/2770287.                            JCM, Wallinga J. The effects of influenza 
               The authors projected that COVID–19                       14https://jamanetwork.com/journals/jamanet             vaccination of health care workers in nursing 
               would reduce U.S. life expectancy in                    workopen/fullarticle/2777317.                            homes: insights from a mathematical model. PLoS 
               2020 by 1.13 years. Furthermore, the                      15https://www.pnas.org/content/pnas/118/1/             Medicine. 2008; 5:1453–1460. 
                                                                       e2015455118.full.pdf.                                      Lemaitre M, Meret T, Rothan-Tondeur M, et al. 
                                                                         16https://jamanetwork.com/journals/                    Effect of influenza vaccination of nursing home staff 
                 4https://www.ncbi.nlm.nih.gov/pmc/articles/           jamanetworkopen/article-abstract/2782430.                on mortality of residents: a cluster-randomized trial. 
               PMC8354557/.                                              17https://www.medrxiv.org/content/10.1101/             J Am Geriatr Soc. 2009; 57:1580–1586. 
                 5https://jamanetwork.com/journals/jamanet             2021.09.08.21263057v1.                                     29Lemaitre M, Meret T, Rothan-Tondeur M, et al. 
               workopen/fullarticle/2784918.                             18https://journals.plos.org/plosmedicine/              Effect of influenza vaccination of nursing home staff 
                 6https://pubmed.ncbi.nlm.nih.gov/34469474/.           article?id=10.1371/journal.pmed.1003816.                                                             Continued 
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               61558              Federal Register/Vol. 86, No. 212/Friday, November 5, 2021/Rules and Regulations 
               As a result, CDC, the Society for                         in facilities with lower vaccination                     for ongoing healthcare-associated 
               Healthcare Epidemiology of America,                       coverage among staff; specifically,                      COVID–19 transmission risk is 
               and others recommend—and a number                         residents of LTC facilities in which                     sufficiently alarming in and of itself to 
               of states require— annual influenza                       vaccination coverage of staff is 75                      compel CMS to take action. 
               vaccination for health care staff.323334                  percent or lower experience higher rates                    The threats that unvaccinated staff 
                  In addition to preventing morbidity                                                       38 Several            pose to patients are not, however, 
                                                                         of preventable COVID–19.
               and mortality associated with COVID–                      articles published in CDC’s Morbidity                    limited to SARS–CoV–2 transmission. 
               19, currently approved or authorized                      and Mortality Weekly Reports                             Unvaccinated staff jeopardize patient 
               vaccines also demonstrate effectiveness                   (MMWRs) regarding nursing home                           access to recommended medical care 
               against asymptomatic SARS–CoV–2                           outbreaks have also linked the spread of                 and services, and these additional risks 
               infection. A recent study of health care                  COVID–19 infection to unvaccinated                       to patient health and safety further 
               workers in 8 states found that, between                   health care workers and stressed that                    warrant CMS action. 
               December 14, 2020 through August 14,                      maintaining a high vaccination rate is                      Fear of exposure to and infection with 
               2021, full vaccination with COVID–19                      important for reducing                                   COVID–19 from unvaccinated health 
               vaccines was 80 percent effective in                      transmission.394041                                      care staff can lead patients to 
               preventing RT–PCR–confirmed SARS–                            There is also some published                          themselves forgo seeking medically 
               CoV–2 infection among frontline                           evidence from other settings that suggest  necessary care. In a small but 
               workers.35 Emerging evidence also                         similar dynamics can be expected in                      informative qualitative study of 33 
               suggests that vaccinated people who                       other health care delivery settings. For                 home health care workers in New York 
               become infected with the SARS–CoV–2                       example, a recent analysis from Yale                     City, one of the key themes to emerge 
               Delta variant have potential to be less                   New Haven Hospital (YNHH) found                          from interviews with those workers was 
               infectious than infected unvaccinated                     health care units with at least 1                        a keen recognition that ‘‘providing care 
               people, thus decreasing transmission                      inpatient case of HA–COVID–19 had                        to patients placed them in a unique 
                     36                                                                                        42                 position with respect to COVID–19 
               risk.    For example, in a study of                       lower staff vaccination rates.  
               breakthrough infections among health                      Similarly, a small study in Israel                       transmission. They worried . . . about 
               care workers in the Netherlands, SARS–                    demonstrated that transmission of                        transmitting the virus to [their clients].’’ 
               CoV–2 infectious virus shedding was                       COVID–19 was linked to unvaccinated                      They also noted that care for home 
               lower among vaccinated individuals                        persons. In 37 cases, patients for whom                  bound clients might involve other 
               with breakthrough infections than                         data were available regarding the source                 health care staff, and they worried about 
               among unvaccinated individuals with                       of infection, the suspected source was                   ‘‘transmitting COVID–19 . . . to one 
                                         37                                                                                       another.’’44
               primary infections.          Fewer infected               an unvaccinated person; in 21 patients                                    
               staff and lower transmissibility equates                  (57 percent), this person was a                             Anecdotal evidence suggests health 
               to fewer opportunities for transmission                   household member; in 11 cases (30                        care consumers have drawn similar 
               to patients, and emerging evidence                        percent), the suspected source was an                    conclusions—and this, too, has 
               indicates this is the case. The best data                 unvaccinated fellow health care worker                   implications for overall health and 
                                                                                      43                                          welfare in health care settings. For 
               come from long term care facilities, as                   or patient.      While similarly 
               early implementation of national                          comprehensive data are not available for  example, CMS has received anecdotal 
               reporting requirements have resulted in                   all Medicare- and Medicaid-certified                     reports suggesting individuals in care 
               a comprehensive, longitudinal, high                       provider types, the available evidence                   are refusing care from unvaccinated 
               quality data set. Data from CDC’s                                                                                  staff, limiting the extent to which 
               National Healthcare Safety Network                          38https://emergency.cdc.gov/han/2021/                  providers and suppliers can effectively 
               (NHSN) have shown that case rates                         han00447.asp.                                            meet the health care needs of their 
               among LTC facility residents are higher                     39COVID–19 Outbreak Associated with a SARS–            patients and residents. Further, 
                                                                         CoV–2 R.1 Lineage Variant in a Skilled Nursing           nationwide there are reports of 
                                                                         Facility After Vaccination Program — Kentucky,           individuals avoiding or forgoing health 
               on mortality of residents: a cluster-randomized trial.    March 2021.’’ April 21, 2021. Available at https:// 
               J Am Geriatr Soc. 2009; 57:1580–1586.                     www.cdc.gov/mmwr/volumes/70/wr/                          care due to fears of contracting COVID– 
                 Van den Dool C, Bonten MJM, Hak E, Heijne JCM,          mm7017e2.htm.                                            19 from health care workers.454647 
               Wallinga J. The effects of influenza vaccination of         40Postvaccination SARS–CoV–2 Infections                While avoidance of necessary care 
               health care workers in nursing homes: insights from       Among Skilled Nursing Facility Residents and Staff       appears to have abated somewhat since 
               a mathematical model. PLoS Medicine. 2008;                Members — Chicago, Illinois, December 2020– 
               5:1453–1460.                                              March 2021.’’ April 30, 2021. Available at https://      the first months of the COVID–19 
                 30Oshitani H, Saito R, Seiki N, et al. Influenza        www.cdc.gov/mmwr/volumes/70/wr/                          pandemic, it remains an area of concern 
               vaccination levels and influenza-like illness in          mm7017e1.htm.                                            for many individuals.4849 Because 
               long-term–care facilities for elderly people in             41Effectiveness of the Pfizer-BioNTech COVID–19 
               Niigata, Japan, during an influenza A (H3N2)              Vaccine Among Residents of Two Skilled Nursing 
               epidemic. Infect Control Hosp Epidemiol. 2000;            Facilities Experiencing COVID–19 Outbreaks —                44https://jamanetwork.com/journals/ 
               21:728–730.                                               Connecticut, December 2020–February 2021.’’              jamainternalmedicine/fullarticle/2769096). 
                 31https://pubmed.ncbi.nlm.nih.gov/31384750/.            March 19, 2021. Available at: https://www.cdc.gov/          45J Anxiety Disord. 2020 Oct; 75: 102289. 
                 32https://www.cdc.gov/flu/professionals/                mmwr/volumes/70/wr/mm7011e3.htm.                         Published online 2020 Aug 19. Doi: 10.1016/ 
               infectioncontrol/healthcaresettings.htm.                    42Roberts, S., Aniskiewicz, M., Choi, S., Pettker,     j.janxdis.2020.102289 
                 33https://www.cambridge.org/core/journals/              C., & Martinello, R. (2021). Correlation of healthcare      46https://www.cdc.gov/mmwr/volumes/69/wr/ 
               infection-control-and-hospital-epidemiology/              worker vaccination on inpatient healthcare-              pdfs/mm6936a4-H.pdf. 
               article/revised-shea-position-paper-influenza-            associated COVID–19. Infection Control & Hospital           47https://www.nahc.org/wp-content/uploads/ 
               vaccination-of-healthcare-personnel/E83D4D87              Epidemiology, 1–6. Doi:10.1017/ice.2021.414.             2020/03/NATIONAL-SURVEY-SHOWS-HOME- 
               FBBBD80C66A2A4926D00F4B8.                                   43Moriah Bergwerk, M.B., B.S., Tal Gonen, B.A.,        HEALTH-CARE-ON-THE-FRONTLINES-OF-COVID- 
                 34https://www.cdc.gov/phlp/publications/topic/          Yaniv Lustig, Ph.D., Sharon Amit, M.D., Marc             19-AND-CONTINUES-TO-BE-IN-A-FRAGILE- 
               vaccinationlaws.html.                                     Lipsitch, Ph.D., Carmit Cohen, Ph.D., Michal             FINANCIAL-STATE.pdf. 
                 35https://www.cdc.gov/mmwr/volumes/70/wr/               Mandelboim, Ph.D., Einav Gal Levin, M.D., Carmit            48https://www.urban.org/sites/default/files/ 
               mm7034e4.htm?s_cid=mm7034e4_w.                            Rubin, N.D., Victoria Indenbaum, Ph.D., Ilana Tal,       publication/103651/delayed-and-forgone-health- 
                 36https://www.cdc.gov/coronavirus/2019-ncov/            R.N., Ph.D., Malka Zavitan, R.N., M.A., et al. Covid–    care-for-nonelderly-adults-during-the-covid-19- 
               science/science-briefs/fully-vaccinated-                  19 Breakthrough Infections in Vaccinated Health          pandemic_1.pdf. 
               people.html#ref43.                                        Care Workers. N Engl J Med 2021; 385:1474–1484.             49Gale R, Eberlein S, Fuller G, Khalil C, Almario 
                 37https://www.medrxiv.org/content/10.1101/              DOI: 10.1056/NEJMoa2109072. https://                     CV, Spiegel BM. Public Perspectives on Decisions 
               2021.08.20.21262158v1.full.pdf.                           www.nejm.org/doi/full/10.1056/NEJMoa2109072.             About Emergency Care Seeking for Care Unrelated 
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...Federal register vol no friday november rules and regulations authority u s c secretary of labor dates order fr effective date these are on implementation the included in phase with respect to x d n through covid i agricultural establishments where iii eleven or more employees f engaged any given day hand operations field requirements applicable ii that longshoring work under this section maintain a temporary camp identical those set forth at cfr regardless how many part safety health b for construction must be implemented by december citation billing code p is revised read as follows parts january staff who have completed primary vaccination series sections considered met also issued even if they rin au not yet waiting period required full medicare medicaid programs comment assured sec omnibus care consideration comments public law stat received one addresses provided below later than m agency centers reprinted services cms hhs note action interim final rule commenting please refer su...

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