At new 483.460(f), the ICF-IID is required to, at a minimum, document that their staff were provided education regarding the benefits and potential risks associated with the COVID-19 vaccine and that each staff member was offered the vaccine or was provided information on how to obtain it. Simply inquiring about vaccine status violates neither of these laws. CDC has expected pharmacy partners to provide program services on-site at participating facilities for approximately two months from the date of each facility's first vaccination clinic, concluding in all facilities by spring of 2021. Comments must be received on/by June 14, 2021. See MMWR, Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019United States, February 12-March 28, 2020, April 3, 2020, at https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm#T2_down. Accessed at https://www.ssa.gov/OP_Home/ssact/title18/1819.htm; and Social Security Act. Among other things, the National Industrial Recovery Act of 1933 authorized the president to approve codes of fair competition affecting the poultry industry and enabled the executive branch to pass rules prohibiting the interstate transportation of petroleum products. Medicare pays for the administration of the COVID-19 vaccine to beneficiaries, and other public and private insurance providers are required to cover it as well. Turnover of both LTC facility residents (admissions and discharges) and staff can be significant. Centers for Disease Control and PreventionNational Healthcare Safety Network. One obvious example is whether vaccine efficacy will last more than the six months proven to date. https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html. An ICF-IID administrator would likely work with the RN and need to approve the final educational material. This interim final rule has significant potential to support further vaccinations as vaccination opportunities from other sources expand. 7. The accuracy of our estimate of the information collection burden. We believe it would be overly burdensome to mandate that each ICF-IID educate and offer the COVID-19 vaccine to all individuals who enter the facility. The estimates here are based on inferences from scattered data on average length of stay, mortality, job vacancies, news accounts, and other sources that by happenstance are available for one type of facility or type of resident or another. Although we are not establishing formal timeframes within which vaccination must be arranged for new residents, clients, or staff, we expect LTC facilities and ICFs-IID to support vaccination for these individuals as quickly as practicable. For all 15,600 LTC facilities, the burden would be 62,400 burden hours (4 15,600) at an estimated cost of $4,180,800 (4 $67 15,600 facilities). Nonetheless, the tea leaves suggest that the administrative bureaucracy is in for an overhaul with this Supreme Court majority. Similar requirements for large employers, military members and federal contractors all have been struck down, repealed or partially blocked. Given the new and emerging qualities of COVID-19 disease, vaccines, and treatments we recognize that education of clients and staff is critical. and the impetus of the Supreme Court's Olmstead decision. Considering the cost savings from treating seriously ill residents, the financial impact is likely to be positive. [94] A lesser but still very substantial amount of these morbidity costs is for care of gravely ill patients within the nursing home, but reducing those costs is another benefit we are unable to estimate at this time. We do know that large numbers of residents or staff were vaccinated through the Pharmacy Partnership, which for nursing home residents relied most heavily on the CVS and Walgreens drug store chains. CDC. [12] 3. According to Table 1 above, the IP's total hourly cost is $67. CMS knows that everyone working in health care wants to do what is best to keep their patients safe. It must be in a language that they understand and in a format that is accessible to them, such as Braille or large print for a person who is visually-impaired or in American Sign Language for a person who is hearing-impaired. Of those receiving the second vaccine dose, after the 14th day 46 people over the age of 60 became infected and had a severe case, compared to 6 people under the age of 60. COVID-19 Disease and Vaccine Education, b. LTC Facility Residents and Resident Representatives, B. With so many people refusing to be immunized and the virus still a threat, I wrote that employers should do whatever they believe is necessary to make their establishments safe. 47. There are few data sources for this statistic and, thus, it may be out of date. https://www.medicare.gov/care-compare/. The government's power to mandate vaccines in the face of individual recipients' due process and other constitutional objections traces back to the Supreme Court's 1905 decision in Jacobson. For each ICF-IID it would require 3 hours annually (0.25 12) at an estimated cost of $123 ($41 3 hours). Accessed on February 17, 2021. See Marcum Accountants & Advisors, A Five Year Nursing Home Statistical Analysis (2014 to 2018), at https://www.marcumllp.com/wp-content/uploads/marcum-five-year-nursing-home-statistical-analysis-2014-2018.pdf. Harjai reported from Los Angeles and is a corps member for the Associated Press/Report for America Statehouse News Initiative. For example, the website currently has documents entitled Guidance for Group Homes for Individuals with Disabilities and the Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. Read the report to see how your state ranks. [96], To put these cost, benefit, and volume numbers in perspective, vaccinating one hundred previously unvaccinated LTC residents who would otherwise become infected with SARS-CoV-2 and have a COVID-19 illness would cost approximately $54,200 ($542 100) in paperwork, education, and vaccination costs. A growing number of states have enacted legislation directed at employer vaccine mandates. The Rule does not apply to individuals who provide services 100% remotely and do not have any direct contact with patients and/or other staff members. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. We will impose civil money penalties if we determine that the facility has failed to report vaccination data. The information in this RIA and the preamble as a whole would, however, meet the requirements of UMRA. We note that for LTC facilities that participated in the Federal Pharmacy Partnership for Long-Term Care Program, pharmacies worked directly with LTC facilities to ensure staff who received the vaccine also received an EUA fact sheet before vaccination. [83] 85. [37] We note that for LTC facilities participating in the Federal Pharmacy Partnership for Long-term Care Program, pharmacies will work directly with LTC facilities to ensure residents who receive the vaccine also receive an EUA fact sheet before vaccination. If you require legal or professional advice, kindly contact an attorney or other suitable professional advisor. About 40 federal lawsuits have been filed challenging employer or government vaccine mandates. For estimating purposes, we assume that their time is worth about $10.02 an hour (median income of older adults without earnings is $20,440 annually. This estimate of a value per life-year corresponds to 1 year at perfect health. Thus, for each LTC facility the burden for the IP would be 21 hours at a cost of $1,407 (21 hours $67). The Public Health Emergency for COVID-19 ends onMay 11, 2023. In this Issue, Documents The average length of stay for residents of congregate living facilities. 65. Language translations for residents may be available in many facilities from staff, and are virtually always available on demand through services, such as Language Line. Another way to summarize these numbers is in terms of average cost per person newly vaccinated. As discussed above, the ICF-IID administrator would need to obtain approval from the ICF-IID's governing board for the policies and procedures. Our knowledge of the effects of COVID-19 vaccination in LTC facilities comes from several sources, including reporting by Partnership pharmacies and voluntary reporting by some facilities through NHSN. Vaccines, Testing, and Treatment: As a result of the American Rescue Plan Act of 2021 (ARPA), states must provide Medicaid and CHIP coverage without cost sharing for COVID-19 vaccinations, testing, and treatments through the last day of the first calendar quarter that begins one year after the last day of the COVID-19 PHE. Both the medical director and the DON would need to have meetings with the Start Printed Page 26323IP to discuss the development, evaluation, and approval of the policies and procedures. Some examples of evidence of compliance may include sign in sheets, descriptions of materials used to educate, and summary notes from all-staff question and answer sessions. The Biden administration COVID-19 action plan, also called the Path out of the Pandemic, is a substantial increase in the use of vaccination mandates as part of the U.S. federal government response to the COVID-19 pandemic announced by President Joe Biden on September 9, 2021, to be carried out by officials in the Biden administration.The plan included various announced prospective efforts, as . Facilities must develop a similar process or plan for permitting exemptions in alignment with federal law. Clients and residents often live in close quarters. The requirements for LTC facilities and ICFs-IID established by this IFC can be met by offering current and future COVID-19 vaccines authorized by FDA under EUA, or any COVID-19 vaccines licensed by FDA, as well as any COVID-19 vaccine boosters if authorized or licensed. Nursing home residents are less than 1 percent of the American population, but have historically accounted for over one-third of all COVID-19 deaths. For subsequent years, the medical director might need to spend time reviewing or attending meetings to discuss any updates or changes to the policies and procedures; however, that would be a usual and customary business practice. The federal government asked the U.S. Supreme Court to stay the Missouri and Louisiana district court preliminary injunctions that have put the Centers for Medicare & Medicaid Services vaccine mandate on hold in 24 states. https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/. Some congregate living residents require close assistance and support from facility staff, which further reduces their ability to maintain physical distance. If you have other coverage like a Medicare Advantage Plan, review your Explanation of Benefits. Report anything suspicious to your insurer. That is, educational materials and delivery must meet relevant standards in Section 504 of the Rehabilitation Act, which may include making such material available in large print, Braille, and American Sign Language, and using close captioning, audio descriptions, and plain language for people with vision, hearing, cognitive, and learning disabilities. According to the chart above, the total hourly cost for the DON is $94. All these data and estimation limitations apply to even the short-term impacts of this rule, and major uncertainties remain as to the future course of the pandemic, including but not limited to vaccine effectiveness in preventing disease transmission from those vaccinated, and the long-term effectiveness of vaccination. The requirements and burden will be submitted to OMB under OMB control number 0938-1363. The average annual cost of a nursing home stay is about $271.98 per day or about $100,000 per year. These figures are approximations, because none of the data that is routinely collected and published on resident populations or staff counts focus on numbers of individuals residing or working in the facility during the course of a year or over time. Biden's plan also involves an. The total burden estimate for the information collection burden in both LTC facilities and ICFs-IID in the first year is 1,277,874 hours (1,107,600 + 170,274) at an estimated cost of $91,250,874 ($79,825,200 + $11,425,674) and in subsequent years the burden is estimated at 866,580 hours (780,000 + 86,580) at a cost of $55,177,044 ($49,826,400 + $5,350,644). QALYs, when multiplied by a monetary estimate such as the Value of a Statistical Life Year (VSLY), are estimates of the value that people are willing to pay for life-prolonging and life-improving health care interventions of any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed explanation). 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 PHSA, the Secretary determined that a PHE exists for the United States to aid the nation's health care community in responding to COVID-19. We expect that most if not all ICFs-IID will use resources developed by other entities as there is a considerable amount of free information on COVID-19 and its vaccines available online. It furnishes states, facilities, regions, and the Government with data regarding problem areas and measures of progress. The RN would need to work with an ICF-IID administrator who would likely provide input and guidance in developing the policies and procedures and would need to approve them before they go before the governing body for approval. Follow the search instructions on that website to view public comments. the official SGML-based PDF version on govinfo.gov, those relying on it for . https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. Immunization education, delivery, and reporting for influenza and pneumococcal vaccines are already a routine part of LTC facilities' infection control and prevention plans. https://www.fda.gov/media/144637/download, https://www.fda.gov/media/144413/download, https://www.fda.gov/media/146304/download. On December 8, 2022, the FDA amended the EUAs of the updated (bivalent) Pfizer-BioNTech (PDF) and Moderna (PDF) COVID-19 vaccines to include use in children down to 6 months old. Medicare will continue to cover vaccines without cost sharing. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues. Age, however, is not anywhere near a perfect indicator of risk since, for example, health care workers and those with immune system disorders face elevated risks from exposure. If youre in a Medicare Advantage Plan, you wont get this benefit through your plan, but you'll get it through Part B. For the education required in subsequent years, the RN would need to ensure that the information regarding COVID-19 vaccines that is provided to the staff, client and the client's representative before requesting consent for each additional dose of the vaccine is current. Table 2Total Cost for COI Requirements for All LTC Facilities. Medicare wont cover over-the-counter (OTC) tests. We estimate that this rulemaking is economically significant as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Check the receipts and statements you get from your provider for any mistakes. The National Law Review is not a law firm nor is www.NatLawReview.com intended to be a referral service for attorneys and/or other professionals. If your first two doses were Pfizer, your third dose should also be Pfizer. ICFs-IIDs were originally conceived as large institutions, but caregivers and policymakers quickly recognized the potential benefits of greater community integration, spawning the growth in the early 1980s of community ICFs-IID with between four and 15 beds. ICRs Regarding the Documentation Requirements in 483.460(a)(4)(vi) and (f), C. Anticipated Costs of the Interim Final Rule, D. Anticipated Benefits of the Interim Final Rule, PART 483REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES, https://www.federalregister.gov/d/2021-10122, MODS: Government Publishing Office metadata, https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/, https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/people-with-disabilities.html, https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-residents.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/disabilities.html, https://www.cms.gov/newsroom/press-releases/cms-releases-nursing-home-covid-19-training-data-urgent-call-action, https://www.modernatx.com/covid19vaccine-eua/providers/language-resources, https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html, https://covidtracking.com/nursing-homes-long-term-care-facilities, https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/#longtermcare, https://www.cdc.gov/vaccines/covid-19/phased-implementation.html#congregate-living-settings, https://aspe.hhs.gov/system/files/pdf/76956/MFIS.pdf, https://www.medicaid.gov/sites/default/files/2019-12/mfp-rtc.pdf, http://www.floridaarf.org/assets/Files/ICF-IID%20Info%20Center/ICFHandoutonwebsite2-14.pdf, https://www.medicaid.gov/medicaid/long-term-services-supports/workforce-initiative/index.html, https://www.cdc.gov/coronavirus/2019-ncov/community/group-homes.html, https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR27550, https://www.federalregister.gov/documents/search?conditions%5Bterm%5D=85FR54820, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094, https://s3.amazonaws.com/media2.fairhealth.org/whitepaper/asset/Risk%20Factors%20for%20COVID-19%20Mortality%20among%20Privately%20Insured%20Patients%20-%20A%20Claims%20Data%20Analysis%20-%20A%20FAIR%20Health%20White%20Paper.pdf, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations.html, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-developmental-disabilities.html, https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/, https://tcf.org/content/commentary/even-nursing-homes-covid-19-racial-disparities-persist/?agreed=1, https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html, https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm, https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, https://www.fda.gov/media/144637/download, https://www.fda.gov/media/144413/download, https://www.fda.gov/media/146304/download, https://pediatrics.aappublications.org/content/145/3/e20193995, https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html, https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships.html, https://covid.cdc.gov/covid-data-tracker/#vaccinations-ltc, https://www.cdc.gov/vaccines/pandemic-guidance/index.html, https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html, https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, https://www.cdc.gov/vaccines/covid-19/vaccination-, https://www.cdc.gov/nhsn/ltc/weekly-covid-vac/index.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html, https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19, https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html, https://www.cdc.gov/nhsn/pdfs/covid19/ltcf/57.158-toi-508.pdf, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance, https://www.ssa.gov/OP_Home/ssact/title18/1819.htm, https://www.ssa.gov/OP_Home/ssact/title19/1919.htm, https://covid.cdc.gov/covid-data-tracker/#datatracker-home, https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00957, https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm, https://www.bls.gov/oes/current/oes291141.htm, https://www.bls.gov/oes/current/oes119111.htm, https://www.bls.gov/oes/current/oes291228.htm#(5), https://www.bls.gov/oes/current/oes433099.htm, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/resource-center.html, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines, https://www.cdc.gov/nchs/nvss/vsrr/COVID19/index.htm, https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/, https://www.medrxiv.org/content/10.1101/2021.02.05.21251139v3.full.pdf, https://www.nejm.org/doi/full/10.1056/NEJMoa2101765, https://www.kff.org/coronavirus-covid-19/issue-brief/covid-19-and-workers-at-risk-examining-the-long-term-care-workforce/, https://fred.stlouisfed.org/series/MEPAINUSA672N, https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor/, https://www.healthline.com/health-news/how-much-will-it-cost-to-get-a-covid-19-vaccine, https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094, https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html, https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis, https://www.cdc.gov/vaccines/covid-19/planning/index.html, https://www.cdc.gov/mmwr/volumes/70/wr/mm7005e2.htm?s_cid=mm7005e2_x, https://ici-s.umn.edu/files/aCHyYaFjMi/risp_2017, https://www.cdc.gov/mmwr/volumes/69/wr/mm6913e2.htm#T2_down, https://pubmed.ncbi.nlm.nih.gov/32743613/, https://pubmed.ncbi.nlm.nih.gov/33483216/, https://www.abc27.com/news/health/coronavirus/official-biden-moving-vaccine-eligibility-date-to-april-19/, https://www.marcumllp.com/wp-content/uploads/marcum-five-year-nursing-home-statistical-analysis-2014-2018.pdf, LTC: Director of Nursing & ICF-IID: Administrator, 483.80(d)(3) Developing Policies and Procedures, 483.80(d)(3)(ii) & (iii) Developing education materials for staff members and residents and residents' Representatives, 483.80(d)(3)(iv) Keeping vaccine information up-to-date and Making necessary changes, 483.80(d)(3)(vi) and (vii) Documentation requirements, 483.83(d)(3)(viii) and (ix) NHSN Reporting, 483.460(a)(4) Developing the policies and procedures, 483.460(a)(4)(ii), (iii), and (iv) Education requirements, 483.460(a)(4)(v) and (f) Documentation requirements.
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