. We are particularly concerned about transplant center patients, who are among the most severely immunocompromised individuals due to anti-rejection medications that ensure the function of transplanted organs. Fear of exposure to and infection with COVID-19 from unvaccinated health care staff can lead patients to themselves forgo seeking medically necessary care. The CDC data collected under this requirement show that vaccination rates for LTC facility staff have stalled, with a 64 percent national average of vaccinated staff according to CDC data as of August 28, 2021, while the number of new LTC facility resident COVID-19 cases reported per week has risen by just over 1455 percent from recorded lows in June 2021 (323 cases in the week ending June 27, 2021; 4701 in the week ending August 22, 2021). Hence, based upon these assumptions, this analysis will assess the burden for all facilities and employees for each provider and supplier type. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. https://doi.org/10.1073/pnas.2014746118 Moreover, it would be hard to devise a system that treated equally and fairly providers of all sizeswhether with 5 or 50 employees. According to Table 3, the IP's total hourly cost is $79. Hence, for each ESRD, the burden for the administrator would be 2 hours at an estimated cost of $194 (2 97). Accessed 10/14/2021. 67. Hence, for each HHA, the burden would be 2 hours at an estimated cost of $194 (2 97). COVID-19 outbreak associated with a SARS-CoV-2 R.1 lineage variant in a skilled nursing facility after vaccination programKentucky, March 2021. All Info for H.R.4382 - 118th Congress (2023-2024): To require the Secretary of Agriculture to conduct a study on the accessibility of addiction and mental health care providers and services for farmers and ranchers who have been impacted by severe and persistent drought, extreme weather events, instability in the commodities market, misinformation targeting consumers, and for other purposes. LTC facility staff vaccination rates range from lows of 56 percent to highs of over 90 percent, depending upon the State. 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. These requirements are set forth in 418.52 through 418.116. Kaiser Family Foundation, COVID-19 and Workers at Risk: Examining the Long-Term Care Workforce, April 23, 2020, at Conditions for certification for RHCs and Conditions of Coverage for FQHCs are found at 42 CFR part 491, subpart A. RHCs and FQHCs, as essential contributors to the health care infrastructure in the U.S., provide care and services to medically underserved areas and populations. As discussed above, the revision and approval of these policies and procedures would also require activities by the DON and medical director. Section 1819(d)(4)(B) of the Act. The administrator would need to spend time attending governing body meetings to discuss and obtain approval for the policies and procedures; however, that would be a usual and customary business practice. 122. Hence, the burden for these documentation requirements for all 5,780 ICFs-IID would be 6,664 (0.0833 80,000) hours at an estimated cost of $459,816 (6,664 $69). We note that the vaccination policies required in this IFC apply to all individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or other arrangement. Currently, there are 4,933 Medicare-and Medicaid-certified RHCs and 10,384 FQHCs that participate in the Medicare and Medicaid programs in the U.S. For the administrators in all 6,071 ASCs, the burden would be 12,142 hours (2 6,071) at an estimated cost of $1,189,916 ($196 6,071). 246. (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. As estimated in Table 6, the number of unvaccinated health care workers still remains in the millions despite recent progress. In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients. The effects of influenza vaccination of health care workers in nursing homes: insights from a mathematical model. Deaths from COVID-19 in unvaccinated LTC facility residents during 2020 were about 130,000, or close to one tenth of the average LTC facility resident census of 1.4 million, a huge contrast to the handful of deaths in the vaccination results from Israel. Emanuel, E and Skorton, D. Mandating COVID-19 Vaccination for Health Care Workers. (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section; and. [232] These services are rehabilitative and generally last only days, weeks, or months. [81] The ICP would conduct research and then either modify or develop the policies and procedures needed to comply with this section's requirements. Available data also continue to suggest that the majority of COVID-19 cases and hospitalizations are occurring among individuals who are not fully vaccinated. While employers have the flexibility to establish their own processes and procedures, including forms, we point to The Safer Federal Workforce Task Force's request for a religious exception to the COVID-19 vaccination requirement template as an example. 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. Annals.org. APIs are the foundation of smartphone applications (apps). Start Printed Page 61576 Employers should first determine whether the Rule applies to their entity, and if so, to which particular staff it applies. Despite the near-universal applicability of the requirements described in sections II.A.1. The ESRD CfCs were initially issued in 1976 and were comprehensively revised in 2008 (73 FR 20370). 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). The accuracy of our estimate of the information collection burden. [191192193] https:// 93. Emerging evidence also suggests that vaccinated people who become infected with Delta have potential to be less infectious than infected unvaccinated people, thus decreasing transmission risk. The ICRs for this section would require each CORF to develop the policies and procedures needed to satisfy all of the requirements in this section. 33. Since we estimate that about 2.4 million employees will need to be vaccinated (or replaced) in the first year (rightmost column of Table 6), most in the first two months after this rule is published, total costs would be about $180 million. For those patients recovering from severe COVID-19 illness with long-term symptoms, prompt comprehensive outpatient rehabilitation services upon their discharge from inpatient care is necessary to restore physical and mental health. According to Table 3, the total hourly cost for the DON is $96. The authority citation for part 416 continues to read as follows: Authority: a. This estimate assumes that the 2.4 million will be some mix of existing and replacement staff. should verify the contents of the documents against a final, official Likewise, 42 CFR 491.2 defines a FQHC as an entity as defined in 405.2401(b). The requirements and burden will be submitted to OMB under OMB control number 0938-1091 (expiration date November 30, 2022). 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. 135. [85] 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. (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43. This document has been published in the Federal Register. https://www.cdc.gov/nhsn/covid19/ltc-vaccination-dashboard.html;; are not part of the published document itself. Because these patients are at home, essential care must be provided, regardless of COVID-19 vaccination or infection status. https://academic.oup.com/cid/article/72/12/e993/6024509?login=true. among other sources. We assume that these efforts occur during paid working hours and that all costs will be borne by the facility. Providers and suppliers have the flexibility to use the appropriate tracking tools of their choice. [Updated] CMS Proposes 2.2% Decrease To Home Health Provider Medicare According to Table 3, the total hourly cost for the administrator is $122. vaccinatedthat is, staff for whom it has been 2 weeks or more since they completed a primary vaccination series for COVID-19, with the completion of a primary vaccination series for COVID-19 defined as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. 133. We believe that this would require an RN 5 minutes or 0.0833 hours to perform the required documentation an adjusted hourly wage of $77 for each employee. 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. Dialysis facility rates derived from data reported through CDC's NHSN and posted online at the Dialysis COVID-19 Vaccination Data Dashboard: 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. accessed October 18, 2021. Potter J, Stott DJ, Roberts MA, et al. https://www.fda.gov/media/144637/download. According to Table 3, an RN working with for a HIT supplier would have a total hourly cost of $73. Because According to Table 3, CMHCs have 140,000 employees. This is not a robust estimate but is supported by several sources. However, the Rule does not apply to staff who telework full-timethat is, 100% remotelyfor example, employees that provide remote telehealth or payroll services. Furthermore, the WHO maintains a list of COVID-19 vaccines for emergency use. 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 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. 99. legal research should verify their results against an official edition of Both variables, in turn, may depend in significant ways on the overall labor market and on the ability of telehealth measures to replace in-person staff to patient encounters. 119. For the number of employees for each provider and supplier, those numbers were obtained from Table 5: Estimates of Number of Staff by Type of Provider (thousands) located in section VI.B. Prevalence of underlying medical conditions among selected essential critical infrastructure workersbehavioral risk factor surveillance system, 31 states, 2017-2018. 234. Transplant centers, psychiatric hospitals, and swing beds are governed by the infection control CoPs for hospitals, and are thus subject to the staff vaccination requirements issued in this IFC. At age 80, the average life expectancy of a male is about 8 years and of females about 10 years, or an overall average of about 9 years. (x) Contingency plans for staff who are not fully vaccinated for COVID-19. The conditions were issued on June 12, 1992 (57 FR 27106), and the conditions related to staffing and staff responsibilities were last updated on May 12, 2014 (79 FR 27106). Internal estimates based on data published at As explained in the HHS Guidelines, the average individual in studies underlying the VSL estimates is approximately 40 years of age, allowing us to calculate a value per life-year of approximately $590,000 and $970,000 for 3 and 7 percent discount rates respectively. Follow the search instructions on that website to view public comments. [170] *For additional information, please contact one of the authors or the Epstein Becker Green attorney who regularly handles your legal matters. With regard to recognized clinical contraindications to receiving a COVID-19 vaccine, facilities should refer to the CDC informational document, Start Printed Page 61592 corresponding official PDF file on govinfo.gov. 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. As shown in Table 6, it is normal for there to be roughly 2.66 million new hires (column two) in the health care settings we address in this rule, compared to a baseline of roughly 10.4 million staff (column one). Transmission of SARS-CoV-2 from asymptomatic and presymptomatic individuals in healthcare settings despite medical masks and eye protection. [206] 43. We expect to make a determination based on public comments, incidence, disease outcomes, and other factors regarding whether it will be necessary to conduct final rulemaking and make this rule permanent. Therefore, the total burden for all 5,556 hospices for this rule would be 83,882 (55,560 + 28,322) hours at an estimated cost of $7,104,494 (4,867,056 + 2,237,438). Hospice patients may also be served in inpatient facilities, including those operated by the hospice itself. and invite public comment on the proposed rule before the provisions of the rule take effect, in accordance with the Administrative Procedure Act (APA), 5 U.S.C. The ONC Final Rule identifies and finalizes the reasonable and necessary activities that do not constitute information blocking while establishing new rules to prevent information blocking practices (e.g., anti-competitive behaviors) by healthcare providers, developers of certified health IT, health information exchanges, and health information networks as required by the Cures Act. Accessed 10/16/2021. https://doi.org/10.7326/M21-3150. Infect Control Hosp Epidemiol And multiple studies have demonstrated SARS-CoV-2 transmissions between health-care workers and patients in hospitals, despite universal masking and other protocols. See Rebecca Robbins, Merck Says It Has the First Antiviral Pill Found to Be Effective Against Covid, The New York Times, October 1, 2021. Each CMHC will need to review their current policies and procedures and modify them, if necessary, to ensure compliance with the requirements in this IFC. widespread availability of vaccines, and targeted efforts to facilitate vaccine access like the Federal Retail Pharmacy program,[66] and solicit public comment before a collection of information requirement (ICR) is submitted to the Office of Management and Budget (OMB) for review and approval. Start Printed Page 61560 229. According to Table 3, the administrator's total hourly cost is $98. We estimate that the average cost of a vaccination is what the government pays under Medicare: $20 2 = $40 for two doses of a vaccine, and $20 2 for vaccine administration of two doses, for a total of $80 per employee. 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. 94. Although an individual is not considered fully vaccinated until 14 days (2 weeks) after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have meet the individual vaccination requirements, even if they have not yet completed the 14-day waiting period. The risk of death in this age group is one tenth that of those aged 65-74. The first IFC, Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program (FR27550) was published on May 8, 2020. Home-based care providers provide necessary care and services for individuals who need ongoing therapeutic, and in some cases life-sustaining, care. on NARA's archives.gov. For the administrators in all 2,078 organizations, the burden would be 4,156 hours (2 2,078) at an estimated cost of $407,288 (4,156 98). According to Table 3, ESRD facilities have 170,000 employees. Further, most of these reinfections. Effect of influenza vaccination of nursing home staff on mortality of residents: a cluster-randomized trial. 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. [195] Therefore, activities for the administrator associated with governing body approval for the policies and procedures are exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). We define completion of a primary vaccination series as having received a single-dose vaccine or all doses of a multi-dose vaccine. (i) A process for ensuring all staff specified in paragraph (b)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (b)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iv) A process for tracking and securely documenting the COVID-19 vaccination status for all staff specified in paragraph (b)(1) of this section; Secretary, Department of Health and Human Services. 9. Section 441.151(c) requires psychiatric residential treatment facilities (PRTFs) to develop and implement policies and procedures to ensure their staff are vaccinated for COVID-19 and that appropriate documentation of those vaccinations are tracked and maintained. 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. https://jamanetwork.com/journals/jama/fullarticle/2773128. This table of contents is a navigational tool, processed from the Each facility must maintain documentation of their staff's vaccination status. Accessed 10/6/2021. Roberts, S., Aniskiewicz, M., Choi, S., Pettker, C., & Martinello, R. (2021). Accordingly, we require that providers and suppliers included in this IFC establish and implement a process by which staff may request an exemption from COVID-19 vaccination requirements based on an applicable Federal law. As noted above, various populations are directly or indirectly affected by this rule. The risk of severe COVID-19 also increases as the number of underlying medical conditions increases in a particular individual. 147. 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. As discussed above, the revision and approval of these policies and procedures would also require activities by an administrator. [225] [226] (2 7,893) at an estimated cost of $1,531,242 (7,893 194). Section 460.74(d) also requires PACE organizations to track and securely maintain the required documentation of staff COVID-19 vaccination status. Section 486.525(c) also requires HIT suppliers to track and securely maintain the required documentation of staff COVID-19 vaccination status. It also includes essential demographic data to support patient matching across care settings. Section 418.60(d) also requires hospices to track and securely maintain the required documentation of staff COVID-19 vaccination status. 202-690-6145. We estimate this would require 2 hours each for the physician, nurse practitioner, and physician assistant. FDA's website includes letters of authorization and fact sheets and these documents should be checked for any updates that may occur. For these reasons and the reasons set forth in section II.A. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918. 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 ( (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospice's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; 5. [136] . 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. 213. The providers and suppliers regulated under this rule are diverse in nature, management structure, and size. Interim Public Health Recommendations for Fully Vaccinated People Thus, COVID-19 vaccination mandates will provide patients and their household members with safety assurances that will facilitate acceptance of home care services, and will protect the patients, staff, and the other members of the patients' households. CDC data show that across the U.S., physicians and advanced practice providers have significantly higher vaccination rates than aides. 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. Accessed 10/06/2021. procedures is 1,410 hours (1,128 + 282) at an estimated cost of $117,876 (83,472 + 34,404). 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). that the vaccinations, and hence the benefits and costs, estimated for this rule are more or less simultaneously being created voluntarily by some employers (self-mandates), through the OSHA vaccination rule applicable to employers of 100 or more persons, and by some State or local mandates. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html. 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 (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with patients and other staff specified in paragraph (b)(1) of this section. As discussed above, the revision and approval of these initial policies and procedures would also require activities by the ASC administrator. CMHCs provide the set of mental health care services specified in section 1913(c)(1) of the PHS Act (or, in limited circumstances, provides for such service by contract with an approved organization or entity). 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. 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 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. HHS's Guidelines for Regulatory Impact Analysis outline a standard approach to valuing the health benefits of regulatory actions. 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. https://www.bridgemi.com/michigan-health-watch/despite-protests-98-henry-ford-hospital-workers-get-covid-vaccinations accommodations for some individual staff members in some circumstances. On March 2, 2021, CDC issued Interim Considerations for Phased Implementation of COVID-19 Vaccination and Sub Prioritization Among Recommended Populations, which notes that increased rates of transmission have been observed in these settings, and that jurisdictions may choose to prioritize vaccination of persons living in congregate settings based on local, State, tribal, or territorial epidemiology. Thus, for each HHA, the burden for the RN would be 8 hours at a cost of $584 (8 hours 73).