# Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2021-23831 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** November 5, 2021 - **Citation:** 86 FR 61555 ## Text 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. 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. 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 press@cms.hhs.gov. 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) (§ 416.51) • Hospices (§ 418.60) • Psychiatric residential treatment facilities (PRTFs) (§ 441.151) • Programs of All-Inclusive Care for the Elderly (PACE) (§ 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) (§ 482.42) • Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80) • Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430) • Home Health Agencies (HHAs) (§ 484.70) • Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70) • Critical Access Hospitals (CAHs) (§ 485.640) • Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725) • Community Mental Health Centers (CMHCs) (§ 485.904) • Home Infusion Therapy (HIT) suppliers (§ 486.525) • Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8) • End-Stage Renal Disease (ESRD) Facilities (§ 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 1 https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx. 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 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. 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 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/. 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 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. 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 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 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. 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 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. 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. 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 . 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 44 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096 ). 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 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 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 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 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%20in%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 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 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 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. 101 101 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. 103 104 105 102 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. 106 106 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 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 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. 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. 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. ER05NO21.022 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 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 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) • 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 § 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 § 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 § 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 § 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 § 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 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 rece [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2021-23831. Public record. Not legal advice.