However, COVID-19 is more infectious and has greater rates of mortality, hospitalizations, and severe illness than influenza. 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). [183] When you respond favorably to a customers claim, you need to write an adjustment letter. Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours 79). For our estimates, we assume a 10 percent hospitalization rate among people aged 65 years or older in LTC facilities, reflecting both that their conditions are significantly worse than those of similarly aged adults living independently, and that pre-hospitalization treatments have improved. 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. Written communications fall into two categories: paper-based and electronic. The HHA must also have a contingency plan for all staff not fully vaccinated according to this rule. 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. The LTC facility must also have a contingency plan for all staff not fully vaccinated according to this rule. COVID-19 Vaccination of facility staff. [43] https://academic.oup.com/cid/article/72/12/e993/6024509?login=true. Start Printed Page 61602 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. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. 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. 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. accessed 10/6/21, 1:02 p.m. EDT. I drove to the city and stopped by the office. Accessed on August 30, 2021. 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. Start Printed Page 61575. Start Printed Page 61598 [9101112] Accessed February 11, 2021. Pursuant to the statutory requirement set out at section 1861(p)(4)(A) and (B) of the Act, the furnishing of such services by a clinic, rehabilitation agency, or public health agency must meet such conditions relating to health and safety as the Secretary may find necessary. documents in the last year, by the Rural Utilities Service [323334], 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. Similarly, the U.S. experienced a large COVID-19 wave in the winter of 2020. https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm. [13] For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. Accessed at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html. Therefore, the Department has determined that this IFC will not have a significant economic impact on a substantial number of small entities and that a final RIA is not required. 255. Section 1905(h) of the Act defines inpatient psychiatric hospital services for individuals under 21 as any inpatient facility that the Secretary has prescribed in regulations that in the case of any individual involve active treatment which meets such standards as may be prescribed in regulations by the Secretary. For the purposes of determining the COI burden, we will assume that the therapist is a physical therapist. In the case of the OPO rule, an entire organization had to be slowly reformed to achieve compliance. Individuals experiencing respiratory problems, cardiac events, kidney failure, and other serious effects of COVID-19 illness have required in-hospital care in large numbers, to the point of occupying or even exceeding most or all critical care or ICU capacity in a facility, city, or region. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769096 113. et al The total burden for all 1,358 CAHs would be 5,432 hours (4 1,358) at an estimated cost of $662,704 (1,358 488). We recently put a phased system in place for Organ Procurement Organizations (OPOs), so we are not reflexively opposed to such options. Amend 460.74 by adding paragraph (d) to read as follows: (d) For this rule, we have also added a new paragraph at 483.80(i)(2), which specifies which staff for whom the requirements for staff COVID-19 vaccination will not apply: (1) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply) and (2) staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff (for whom the requirements do apply). 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. We assume that these efforts occur during paid working hours and that all costs will be borne by the facility. This is not surprising: Respiratory virus infections typically circulate more frequently during the winter months, with peaks in pneumonia and influenza deaths typically during winter months. 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. States. Accessed 10/16/2021. the current document as it appeared on Public Inspection on Hence, we use the rough estimate that about 100,000 a day have recovered in recent weeks. Explanation: Providers and suppliers have the flexibility to use the appropriate tracking tools of their choice. The CMHC must develop and implement policies and procedures to ensure that all center staff are fully vaccinated for COVID-19. These and some lesser options are presented and discussed in the main preamble. 19. These CoPs contain specific requirements for infection control and prevention at 485.640. Start Printed Page 61565 Hospitals that provide emergency care must do so in accordance with the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) of 1986. Set an end date when appropriate. Comment date: Kimmel; D.E. Home Infusion Therapy Suppliers (HIT) Suppliers, 4. conjunction. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html. assistant acting within their respective scope of practice as defined by and in accordance with all applicable State and local laws. This EUA has also been amended to allow for use of a single booster dose in certain individuals. Choose the best revision for the following sentence. present the clinical requirements. Amend 491.8 by adding paragraph (d) to read as follows: (d) 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. [255] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation at adjusted hourly wage of $69 for each employee. which of the following sentences are correctly punctuated? Therefore, we will not assess any additional burden for the documentation requirements in this rule. New Documents Using LTC facilities as an example, and assuming that the average rate of death from COVID-19 (following SARS-CoV-2 infection) at typical LTC facility resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected value of each resident who would, in the absence of this rule, otherwise be infected with SARS-CoV-2 is about $575,000 ($11.5 million .05). 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. https://www.cdc.gov/mmwr/volumes/70/wr/mm7029a1.htm. In addition, it is likely that those facilities would not comply with all of the requirements in this rule. ICFs-IID are residential facilities that provide services for people with intellectual disabilities. 171. 124. True. https://news.christianacare.org/2021/09/safe-care-safe-workplace-we-are-vaccinated/. c. https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/. Start Printed Page 61590 9. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. https://www.acpjournals.org/doi/10.7326/M21-2366. Since we have no reliable means to estimate the number of hospitals that may have already addressed COVID-19 vaccination of their staff, we will base our estimate for these requirements on all 5,194 hospitals. [230] https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths. For example, many facilities might not define employees as set forth in this rule. https://aspe.hhs.gov/sites/default/files/documents/c5d0dde224c224dd726694367846b609/aspe-covid-medicare-vaccine-analysis.pdf. 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. https://www.nejm.org/doi/full/10.1056/nejmoa2108891. documents in the last year. The receivers of the memo are . 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. In order to ensure that providers and suppliers are complying with the vaccination requirements of this IFC, we are requiring that they track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination, such as recent receipt of monoclonal antibodies or convalescent plasma. 218. Direct claim letters are taken more seriously than e-mails and provide a written account of what Updated October 13, 2021. As discussed previously, it is possible there may be disruptions in cases where substantial numbers of health care staff refuse vaccination and are not granted exemptions and are terminated, with consequences for employers, employees, and patients. CMS is the Federal agency responsible for establishing health and safety regulations for Medicare- and Medicaid-certified providers and suppliers. For the administrators in all 159 organizations, the burden would be 1,272 hours (8 159) at an estimated cost of $124,656 (784 159). The three primary goals of an adjustment letter are rectifying the wrong, regaining customer Choose the best revision to the following sentence. https://covid.cdc.gov/covid-data-tracker/#datatracker-home. 108. However, each hospital would need to review their current policies and procedures and modify them, if necessary, to ensure compliance with all of the requirements in this IFC, especially that their policies and procedures cover all of the eligible facility staff identified in this IFC. The agency has considered other alternatives (for example, relying entirely on measures such as voluntary vaccination, source control alone, and social distancing) and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the statute. https://www.pnas.org/content/118/1/e2015455118. Identify which rule applies to the following sentence. Copyright 2022 by The On-Campus Writing Lab& The OWL at Purdueand Purdue University. While this IFC does not expressly require COVID-19 vaccine counseling or education, we anticipate that some providers and suppliers will conduct such activities as a part of their procedures for ensuring compliance with the provisions of this rule. 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. while you work and (10) .. professional development is expected. notices. Close Explanation [56] (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (n)(1) of this section. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. 42 CFR 491.7. 101. l302 and l395hh. COVID-19 vaccination thus remains an important tool for decreasing stress on the U.S. health care system during ongoing circulation of influenza. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. 1302 and 1395(hh). A.giving up B.looking . 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. 234. 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. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. This rule would pre-empt some State laws that prohibit employers from requiring their employees to be vaccinated for COVID-19. Start Printed Page 61569 70. The first sentence has been done as an example. The body should provide an explanation of the facts in an unemotional and logical manner, so the For a discussion of this issue, see Sumathi Reddy, How Long Do Covid-19 Vaccines Provide Immunity?, The Wall Street Journal, April 13, 2021, at Kaiser Family Foundation, COVID-19 and Workers at Risk: Examining the Long-Term Care Workforce, April 23, 2020, at [80] 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. Another piece of evidence, in addition, which can be seen by anyone who wishes to check, is the following: the sun and the moon look like they are about the same size, roughly, but in fact they are quite different in size. We estimate this would require 2 hours. that agencies use to create their documents. In addition, by going into patients' homes, HHA employees are exposed to numerous individuals who might not be vaccinated or perhaps are asymptomatic but infected. https://www.bls.gov/oes/current/oes_nat.htm. 13. For staff members who request a medical exemption from vaccination, all documentation confirming recognized clinical contraindications to COVID-19 vaccines, and which supports the staff member's request, must be signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. 109. [143] 57. More information and documentation can be found in our [116117] communication channels include e-mail, instant messages, text messages, podcasts, blogs, and wikis. As such, we chose not to require such testing for now but welcome comment. 2. Start Printed Page 61594 I. The closing requests a 03/01/2023, 207 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267626/. B. Section 1820 of the Act sets forth the conditions for certifying a facility as a CAH to include meeting such other criteria as the Secretary may require. FILE 20210925 2013 31 Revision -TACN DUOC(UNIT 1,2) More info. Fewer infected staff and lower transmissibility equates to fewer opportunities for transmission to patients, and emerging evidence indicates this is the case. Prepare for SBI Clerk with best Test Series for SBI Clerk exam at Testzone. [186] Read the text below and choose ONE suitable word from the given ones to fill in each 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. For the physicians in all 15,317 RHCs/FQHCs, the burden would be 30,634 hours (2 15,317) at an estimated cost of $6,494,408 (424 15,317). 89. Start Printed Page 61608 of this IFC, we are adding a new regulatory requirement at 483.430(g) related to establishing and implementing policies and procedures for COVID-19 vaccination of all staff (includes employees; licensed practitioner; students, trainees, and volunteers; and other individuals) who provide care, treatment, or other services for the provider or its patients. In order to provide protection as soon as possible, we are establishing two implementation phases for this IFC. There remain many uncertainties about as to the strength and length of this immunity compared to people who are vaccinated, andin recognizing thatthe CDC recommends that previously infected individuals get vaccinated. answer choices. 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. Current regulations at 483.470(l) Standard: Infection control requires that the ICFs-IID must provide a sanitary environment to avoid sources and transmission of infections. See Reductions in 2020 US life expectancy due to COVID-19 and the disproportionate impact on the Black and Latino populations. The hospital must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/disparities-impact.html. Data from CDC's National Healthcare Safety Network (NHSN) have shown that case rates among LTC facility residents are higher in facilities with lower vaccination coverage among staff; specifically, residents of LTC facilities in which vaccination coverage of staff is 75 percent or lower experience higher crude rates of preventable SARS-CoV-2 infection. In this case, however, the priority for older adults (virtually all of whom have risk factors) who comprise the majority of hospital inpatients and the vast majority of LTC facility residents has already been established and is largely met. Explanation: The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. However, this comparison should be taken as necessarily hypothetical and contingent due to the analytic, data, and uncertainty challenges discussed throughout this regulatory impact assessment. 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