(ii) Before offering COVID-19 vaccine, all staff members are provided with education regarding the benefits and risks and potential side effects associated with the vaccine. I suspect some employers silently welcomed Bidens mandate. All facilities must adhere to current CDC infection prevention and control (IPC) recommendations. on For example, there is insufficient evidence as to whether the current or reasonably foreseeable vaccines will maintain their protective efficacy for more than six months. In commenting, please refer to file code CMS-3414-IFC. 33. The Kaiser Family Foundation estimates as of February 22 that to date 37 percent of all health care workers (not specific to LTC workers) have declined vaccination or decided to wait and see. Clients and residents often live in close quarters. I was . Despite their inclusion in most states' tier 1 vaccine priority category, it is CMS's understanding that very few individuals who are residents of LTC facilities are likely able to independently schedule or travel to public offsite vaccination opportunities. We are requiring that ICF-IID staff (that is, individuals who are eligible to work in the facility on a routine, or at least once weekly, basis) be educated about the benefits and risks and potential side effects of the COVID-19 vaccine. 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). Only about 13% have private sources of payment. For education of staff, we make similar assumptions, except that early and anecdotal evidence suggests that a third or more are declining vaccination. Elimination of Paper Documentation in Streamlined Entry Process NLRB Will Not Stop Short in Imposing Remedies for Failure to Bargain, A Definitive Guide to Master Law Firm Business Development. 42 U.S.C. [6] COVID-19 Vaccines. New Antidumping and Countervailing Duty Petition on Non-Refillable Steel Cylinders I-9 Verification and Compliance: Navigating New Nuances Post-COVID, Foreign Sponsors Breaking Into The Us Renewables Market: Challenges And Solutions, Labor and Employment Update for Employers May 2023, Global Mobility Opportunities And Challenges: How To Navigate A Global Workforce. Making the same assumption that about 5 percent of total persons (and 10 percent of those unvaccinated) would be newly vaccinated as a result of this rule, cost per person would be $542 ($27.12 divided by .05). documents in the last year, 887 If you are using public inspection listings for legal research, you You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3414-IFC, P.O. on NARA's archives.gov. [35] We estimate that this would require one quarter or 0.25 hour per month per facility and that this task would be performed by administrative staff, probably a financial clerk. Check the receipts and statements you get from your provider for any mistakes. After a review of all available information, ACIP and CDC have determined the lifesaving benefits of COVID-19 vaccination outweigh the risks or possible side effects.[26]. The first IFC was the 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 interim final rule with comment, which appeared in the May 8, 2020 Federal Register (85 FR 27550) with an effective date of May 8, 2020 (hereafter referred to as the May 8th COVID-19 IFC). We expect that most if not all LTC facilities will use resources developed by other entities as there is a considerable amount of free information on COVID-19 and vaccines available online. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (Expiration Date 6/30/2022). But I dont believe in government requirements on private employers. We strongly encourage facilities, when the opportunity exists and resources allow, to provide vaccination to all individuals who provide services less frequently. It also does not prevent individuals from responding to such a question. documents in the last year, 125 Its about getting people vaccinated, to protect them and those around them wherever they go. 29-1141 Registered Nurses. Since the Administrations announcement, nursing home staff vaccination rates have increased by approximately nine percentage points from 62 to 71 percent. Departments Release Update on No Surprises Act Independent Dispute FY 2024 H-1B Registration Period Indicates 780,884 Registrations; A Look Back at Key Takeaways from RSA Conference 2023. Beginning her legal education with the goal of becoming a practicing healthcare attorney, Ms. Kuta is privileged to concentrate her practice in this area of law. The requirements apply to: Ambulatory Surgical Centers, Hospices, Programs of All-Inclusive Care for the Elderly, Hospitals, Long Term Care facilities, Psychiatric Residential Treatment Facilities, Intermediate Care Facilities for Individuals with Intellectual Disabilities, Home Health Agencies, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services), Community Mental Health Centers, Home Infusion Therapy suppliers, Rural Health Clinics/Federally Qualified Health Centers, and End-Stage Renal Disease Facilities. Therefore, the Department has determined that this interim final rule will not have a significant economic impact on a substantial number of small entities and that a final RIA is not required. We also request comment on inequities in COVID-19 preventive care that may have been experienced by LTC facility residents and ICF-IID clients. 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. Diane Corning, (410) 786-8486, Lauren Oviatt, (410) 786-4683, Kim Roche, (410) 786-3524, or Kristin Shifflett, (410) 786-4133, for all rule related issues. Accessed on March 18, 2021. For a discussion of this issue, see Sumathi Reddy, How Long To Covid-19 Vaccines Protect You?, The Wall Street Journal, April 13, 2021, at https://www.wsj.com/articles/how-long-do-covid-19-vaccines-provide-immunity-11618258094. Agencies make rules and regulations affecting stock markets, consumer-product safety, the use and trafficking of firearms, environmental protection, workplace discrimination, agriculture, aviation, radio and television communications, financial institutions, federal elections, natural gas and electricity, the construction and maintenance of highways, imports and exports, human and veterinary drugs, and even the licensing and inspection of nuclear-power plants. of this rule, are also seen within LTC facilities. Screening individuals for suspected or confirmed cases of COVID-19, previous allergic reactions, and administration of therapeutic treatments is important for determining whether they are appropriate candidates for vaccination at any given time. To enhance our future efforts to support reasonable and effective COVID-19 vaccination programs in congregate living facilities, we seek public comment on a number of issues, including the following: Where such data are available, we are requesting respondents include data indicating: We acknowledge the lengths that congregate living and HCBS providers have gone to keep their residents, clients, and staff as safe as possible during the COVID-19 PHE, and request their input on ways that CMS and HHS can further support safety and reduce the risk of infection moving forward. 40. What is instead potentially at stake is Congresss authority to hand off regulatory power to unelected executive-branch-agency personnel writ large, which has long been a point of debate among lawyers, judges, and academics. Lastly, we request public comment on challenges congregate living settings might encounter in complying with these IFC provisions, including in reporting vaccine information to CDC's National Healthcare Safety Network (NHSN). This includes current staff and any new staff who will provide care, treatment or other services to the Facilities and/or their patients. About 40 federal lawsuits have been filed challenging employer or government vaccine mandates. We acknowledge the diversity and complexity of the needs of congregate living facilities. If a facility does not have access to the vaccine, we expect the facility to provide, upon request, evidence that efforts have been made to make the vaccine available to its residents or clients, and staff. See the Healthline article at https://www.healthline.com/health-news/how-much-will-it-cost-to-get-a-covid-19-vaccine. [13] However, this comparison is should be taken as necessarily hypothetical and contingent due to the analytic, data, and uncertainty challenges discussed throughout this regulatory impact assessment. 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. Since residents are rarely in the labor market while in the facility, this base income has not been adjusted for fringe benefits or employer expenses. Facilities covered by this regulation must establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 6, 2021. That said, the description in this ruleindividuals who work in the facility on a regular (that is, at least once a week) basisstill includes many of the individuals included in paragraph (h). 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 . The president went too far. Because the first cohort of authorized vaccines require specialized handling, and LTC facility residents have been at higher risk of severe illness from COVID-19, CDC established the Pharmacy Partnership for Long-Term Care (LTC) Program, which has facilitated on-site vaccination of residents and staff at more than 63,000 enrolled nursing homes and assisted living facilities while reducing the burden on facility administrators, clinical leadership, and health departments. Also, we note that some individuals declined the vaccine when it was first offered; approximately 22 percent of LTC facility residents and 62 percent of LTC staff[63] Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html. Accessed at https://www.ssa.gov/OP_Home/ssact/title18/1819.htm; and Social Security Act. An employer may not simply condition eligibility for medical benefits on vaccination. Updates to CDC's COVID-19 Vaccination Program Provider Agreement Requirements can be located on CDC's website.[40]. 91. Staff and resources are limited in ICFs-IID, and therefore staff may not be available to educate and offer the vaccine to every individual that enters. Accessed on March 23, 2021. [94] 67. We have received, and expect to continue to receive, COVID-19-related FOIA requests. This understanding, in turn, will help CDC make changes to guidance to better protect residents and staff in LTC facilities. 24/7 coverage of breaking news and live events. 24. In subsequent years, the burden would only be for the RN and it would be 34,632 burden hours at an estimated cost of $2,320,344. Accessed on March 23, 2021. Centers for Disease Control and Prevention. Categories are further broken down into environmental, laundry, maintenance, and dietary services; registered nurses (RNs) and licensed practical/vocational nurses; certified nursing assistants, nurse aides, medication aides, and medication assistants; therapists (such as respiratory, occupational, physical, speech, and music therapists) and therapy assistants; physicians, residents, fellows, advanced practice nurses, and physician assistants; and persons not included in the employee categories listed, regardless of clinical responsibility or patient contact, including contract staff, students, and other non-employees.[58]. The FDA provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials; such evaluation continues after a vaccine has been licensed by FDA or authorized for emergency use. https://www.cdc.gov/longtermcare/. The cows love it, suggested that employers should not force vaccines on their employees, make it increasingly uncomfortable for the unvaccinated, Do Not Sell/Share My Personal Information. Staff education must also address risks associated with vaccination, which should include potential side-effects of the vaccine, including common reactions such as aches or fever, and rare reactions such as anaphylaxis. 44. The total costs used in this analysis are indicated in the chart below. However, given the uncertainty and rapidly changing nature of the pandemic, we acknowledge that there will likely need to be significant revisions over time as LTC facilities gain experience with these requirements. Even after the end of this program, remaining unvaccinated residents and staff will benefit from additional education, especially as additional information about vaccine safety and effectiveness is available. Stakeholders report that there are many LTC facility staff and individuals providing occasional services under arrangement, and that the requirements may be excessively burdensome for the facilities to apply the definition at paragraph (h) because it includes many individuals who have very limited, infrequent contact with facility staff and residents. 84. Shared living arrangements within, and the sharing of staff across these and other settings can lead to increased risk of COVID-19 outbreaks. The updated Pfizer vaccine is available for people 5 and older. Which is why the vaccine-mandate cases are such a huge deal. [59] FDA is closely monitoring the safety of the COVID-19 vaccines authorized for emergency use. Regardless of priorities, we know that younger persons are much less likely to experience hospitalization or death after infection. Consequently, the primary medium- to long-run benefit-cost issue is not the general magnitude of likely effects on those who get vaccinated as a result of the rule, but the difficult questions of estimating (1) likely numbers of individuals in both client and staff categories who are likely to be unvaccinated when the rule goes into effect and (2) to be willing to accept vaccination in the coming months and years.[97]. We assume that staff turnover is about as high as in LTC facilities, but that resident turnover is considerably lower since resident mortality is not a major factor. state immunization information system record. As presented in the third numeric column of Table 5, the total number of individuals either residing or working in all of these different facilities over the course of a year is about 5.9 million persons, which is more than twice the annual average number of residents or staff shown in the first numeric column. Nonetheless, many facilities across the country are educating staff, residents, and resident representatives; participating in vaccine distribution programs; and voluntarily reporting vaccine administration. See Jose Ness et al., Demographics and Payment Characteristics of Nursing Home Residents in the United States: A 23-Year Trend, Journal of Gerontology: MEDICAL SCIENCES, 2004, Vol. 81. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3414-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. Stakeholders also report that providing the required education and offering vaccination to these individuals who may only make unscheduled visits to the facility would be extremely burdensome. Double Secret Probation! A growing number of states have enacted legislation directed at employer vaccine mandates. In addition to ongoing education and informational updates for all staff members, we expect that new staff will be screened to determine vaccination status, and potential need for appropriate education on COVID-19 vaccines during their onboarding or orientation. While recommendations for routine staff testing could be linked to vaccination rates in each LTC facility (and thus reduce burden on facilities with adequate rates of vaccine coverage), CDC will not have enough data to assess a change in recommendation without full national participation in COVID-19 vaccination reporting by CMS-certified LTC facilities. 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. [14] The roughly 17 million workers at health facilities that receive Medicare or Medicaid also will have to be fully vaccinated. "The private Medicare health plan enrollment projections for the 2023 Trustees Report are higher than those in the 2022 report," said the Trustees. Accessed on January 26, 2021. 18. https://www.phe.gov/emergency/events/COVID19/Pages/2019-Public-Health-and-Medical-Emergency-Declarations-and-Waivers.aspx. (ix) Therapeutics administered to residents for treatment of COVID-19. The average annual cost of a nursing home stay is about $271.98 per day or about $100,000 per year. Total cost of the educational efforts themselves would be approximately $28,442,000 (849,000 persons .5 hours $67 hourly cost). 8. For our estimates, we assume a 20 percent hospitalization rate among people aged 65 years or older in nursing homes, reflecting both that their conditions are significantly worse than those of similarly aged adults living independently, and that pre-hospitalization treatments have improved. 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. Government shouldnt be making that decision for them. Accessed at https://vaers.hhs.gov/. [28], VAERS is a safety and monitoring system that can be used by anyone to report adverse events with vaccines. That said, resident turnover within a year may be significant, possibly up to 40 percent based on internal CMS estimates. Documentation regarding a resident's medical care is a usual and customary business practice for a health care provider. Comments must be received on/by June 14, 2021. 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. Second- and third-year totals would be lower, perhaps about three-fourths as much, taking into account both fewer remaining unvaccinated needing these efforts, and a sensible reduction in efforts aimed at persons who refuse to consider vaccination. For the reasons discussed above, it is critically important that we implement the policies in this IFC as quickly as possible. [42] Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). https://www.kff.org/racial-equity-and-health-policy/issue-brief/racial-diversity-within-covid-19-vaccine-clinical-trials-key-questions-and-answers/. [82] To view the interim final rule with comment period, visit: To view a list of frequently asked questions, visit: www.cms.gov/files/document/cms-omnibus-staff-vax-requirements-2021.docx, https://www.federalregister.gov/public-inspection/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination, CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Requirements Final Rule (CMS-1766-F), CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Requirements Proposed Rule (CMS-1766-P), Biden-Harris Administration Improves Home Health Services for Older Adults and People with Disabilities, CMS Finalizes Calendar Year 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Expansion, CMS Proposes Calendar Year 2022 Home Health Prospective Payment System Rate Update. Title VII and the ADA, however, limit the ability of employers to do so. Early data also suggests that vaccination offers reduced risk of inadvertently transmitting the virus to patients and other contacts. Bureau of Labor Statistics. The vaccination provider is responsible for mandatory reporting to VAERS of certain adverse events as listed on the Health Care Provider Fact Sheet. These specific data collections replace and refine the current requirement, set out at 483.80(g)(1)(viii), based on the opportunities presented by the development and authorization of COVID-19 vaccines and therapeutic treatments. the Federal Register. Thus, for each ICF-IID, the burden for the RN would require 13 burden hours at an estimated cost of $871 (13 $67). Much of the immediate need for LTC resident and staff education has already been accomplished through the Pharmacy Partnership for Long-Term Care Program. 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. Secretary, Department of Health and Human Services. Accessed on February 17, 2021. In 2021, that threshold is approximately $158 million. Hence, we believe that it will not require any additional time or burden to develop the educational materials for the residents and resident representatives. Individualized counseling, resident meetings, staff meetings, posters, bulletin boards, and e-newsletters are all approaches that can be used to provide education. We seek information from the public regarding the epidemiologic burden of COVID-19 on ICFs-IIDs, reporting COVID-19 data by ICFs-IID, existing barriers to reporting, and ways to enhance and encourage voluntary reporting of COVID-19-related data to CDC's NHSN reporting module. 11. [12] Since the publication of the September IFC, the FDA has issued EUAs for multiple vaccines developed to prevent the spread of SARS-CoV-2. Sound harsh? Health care providers and other covered entities may disclose vaccination information only if authorized by the patient or as permitted by privacy law exceptions; for example, to public health agencies or to an insurer to collect payment. The data show that COVID-19 cases are declining in LTC facilities concurrently with increasing vaccination among residents and staff, but as noted below, we are concerned that the rate of vaccination in LTC facilities may slow in the absence of regulation and the conclusion of the Pharmacy Partnership program, especially in light of consistent, frequent resident and staff turnover in these facilities and the cold storage chain challenges that exist with two of the three currently available vaccines that make obtaining and providing the vaccine more challenging for small facilities that do not have the necessary storage equipment.

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