Therefore, for all ICFs-IID, the total annual burden in the first year for the required policies and procedures would be 77,922 burden hours (60,606 + 17,316) at an estimated cost of $5,688,306 ($4,060,602 + $1,627,704). https://www.cdc.gov/nhsn/pdfs/covid19/ltcf/57.158-toi-508.pdf. The requirements and burden will be submitted to OMB under OMB control number 0938-New. For example, the amounts provided in the Provider Relief Fund is $7.4 billion, many times more than the relatively small costs of this rule. The estimated numbers for ICFs-IID are lower because few residents or staff were eligible for vaccination from any source other than the Partnership in the first three months of the year. These data also show that vaccine effectiveness rates are very high for both older and younger recipients. We estimate 80 percent a year for turnover, the same as for nursing facilities. As explained in the HHS Guidelines, the average Start Printed Page 26332individual in studies underlying the VSL estimates is approximately 40 years of age, allowing us to calculate a value per life-year of approximately $540,000 and $900,000 for 3 and 7 percent discount rates respectively. of this rule), internal CDC data show that approximately 2,500 Medicare or Medicaid-certified LTC facilities (approximately 16 percent) did not participate in the Pharmacy Partnership program. CMS cited substantial compliance with the vaccination requirement while making the change. https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis. 8. We believe that the administrator would likely make a salary similar to that of a manager in the LTC setting, like that for the DON salary as discussed above. The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. Yet the average years of remaining life among younger persons at these ages is far greater than among older persons at higher ages. Reductions in health care costs from hospitalization would produce another $320,000 ($20,000 100 .16) in benefits for this group assuming that 16% would otherwise be hospitalized. The costs and benefits of COVID-19 vaccination services for this group are roughly comparable to those of nursing home staff. Nothing in this rule will have a substantial direct effect on state or local governments, preempt state laws, or otherwise have federalism implications. About the OSH Act, the legal scholar Robert D. Moran commented in 1974: It is doubtful that Congress has ever enacted a broader grant of lawmaking authority to any officer of the executive branch [and] difficult to conceive of anything that does not affect the safety and health of working people; the hours he works, his diet, his state of mind as he leaves the job for each day, and even his sex life . At the time of publication, we do not have data on the Partnership accomplishments in vaccinating residents or staff, but as discussed in the Regulatory Impact Analysis (RIA) section of this rule, there is extensive turnover in both groups, establishing the need for ongoing vaccination policies and programs. To ensure broad access to a vaccine for America's Medicare beneficiaries, CMS published an Interim Final Rule with Comment Period (IFC) on November 6, 2020, that implemented section 3713 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act which required Medicare Part B to cover and pay for a COVID-19 vaccine and its administration without any cost-sharing (85 FR 71142, November 6, 2020). These exceptions are all discussed briefly in the ICR section of this preamble. 20. 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. The second large cluster of costs are for the required resident, client, and staff education. When the vaccine is available to the facility, each resident and staff member is offered COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized. An EUA (authorized under section 564 of the Federal Food, Drug, and Cosmetic Act) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Offer and Provision of Vaccine to ICF-IID Clients and Staff, A. COVID-19 and Populations at Higher Risk, B. Even regular volunteers may enter the ICF-IID infrequently. Some Medicare Advantage Plans might cover and pay for at-home over-the-counter COVID-19 tests as an added benefit. PRTFs only serve children and youth under the age of 21 years, and there is not yet a COVID-19 vaccine authorized or licensed for people younger than the age of 16 years in the United States. The LTC Facility Toolkit: Preparing for COVID-19 Vaccination at Your Facility has information and resources to build confidence among staff and residents. Occupational Employment and Wages, May 2019. Wendy E. Parmet: Americans are suing to protect their freedom from infection. (For the Moderna vaccine, for example, see https://www.modernatx.com/covid19vaccine-eua/providers/language-resources.) 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. 43. This IFC also requires reporting of COVID-19 vaccination status and use of COVID-19 therapeutics of LTC facility residents and staff, which will provide vital data that CMS, CDC, and other public health entities can use to target our outreach and resources in support of vaccination. Updated March 18, 2021. 2006. Assuming that the average rate of death from COVID-19 (SARS-CoV-2 infection) at nursing home resident ages and conditions is 5 percent, and the average rate of death after vaccination is essentially zero, the expected life-extending value of each resident receiving the full course of two vaccines who would otherwise be infected is $125 thousand at a 3 percent discount rate and $185 thousand at a 7 percent discount rate. 61. The burden in the first year for the DON in each LTC facility would be 4 hours at an estimated cost of $376 (4 hours $94). 23. 100. [42] This prototype edition of the Individualized counseling, resident meetings, staff meetings, posters, bulletin boards, and e-newsletters are all approaches that can be used to provide education. This activity would require that the ICF-IID offer the vaccine to the staff member or Start Printed Page 26326resident and have that staff member, client, or client representative complete screening for any contraindication or precautions, and for the client or client representative consent to the vaccination or indicated refusal. New 483.460(a)(4)(iii) requires that ICF-IID clients, or their representatives are educated about vaccination against COVID-19. We note that we are permitting but not requiring LTC facilities to provide the vaccine directly. We acknowledge that many congregate living facilities may not fall into any single category or may be classified differently depending on the state in which they are located. 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. For residents and staff who overcome vaccine hesitancy, it is critical to their health and well-being that they are able to get the vaccine when they are ready to receive it. We also estimate that vaccination reduces the chance of infection by about 95 percent, and the risk of death from the virus to a fraction of 1 percent. 11. If an employer offers the vaccination itself, however, the program must be voluntary because the employer would have to ask screening questions before giving the vaccine that are related to disability or family medical history that are prohibited under the ADA and GINA. The testing component is problematic because it could be costly. Over 569,000 individuals have lost their lives to COVID-19 in the United States as of April 27, 2021,[60] The September 2nd COVID-19 IFC strengthened CMS' ability to enforce compliance with LTC reporting requirements and established a new requirement for LTC facilities to test facility residents and staff for COVID-19. The Centers for Medicare & Medicaid . 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. For residents and staff who opt to receive the vaccine, vaccination must be conducted in a safe and sanitary manner in accordance with 483.80; and as required by the vaccine provider agreements, COVID-19 vaccination clinics must be conducted in a manner for safe delivery of vaccines during the COVID-19 pandemic. As discussed in section B.3. *These costs assume only unvaccinated are educated about vaccination. A longer period would be even more speculative than the current estimates. Kansas, Florida and Texas each declined to check for vaccination violations, instead leaving that process to CMS, which hired contractors. Other factors impacting virus transmission in these settings might include: Clients who are employed outside the congregate living setting; clients who require close contact with staff or direct service providers; clients who have difficulty understanding information or practicing preventive measures; and clients in close contact with each other in shared living or working spaces. We assume that the total number of individual employees is 50 percent higher than the full-time equivalent but that only half that number are primarily employed at only one nursing facility, two offsetting assumptions about the number of employees working at each facility (many employees are part-time consultants or the equivalent who serve multiple nursing facilities on a part-time basis). We encourage voluntary reporting as facilities are able to do so. Thus, reporting in NHSN will, in many cases, serve the needs of state and local health departments. The ACA prohibits discrimination in health benefits based on health, including vaccination status. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date the rule is issued or published. It is difficult to estimate the number of admissions and discharges in LTC facilities as 20 to 25 percent of beds are often reserved for shorter term (weeks to months) rehabilitation stays, while other individuals reside in the facility for years. Much of the immediate need for LTC resident and staff education has already been accomplished through the Pharmacy Partnership for Long-Term Care Program. Vaccine Mandates and Federal Law. These long-term stays are primarily funded by the Medicaid program (also, through long-term care insurance or self-financed), and the residential care services these residents receive are not normally covered by Medicare or any other health insurance. Tagged CMS Coronavirus Medicaid Medicare Medicare Compliance Policy & Regulation Workforce Management 83. https://www.cdc.gov/longtermcare/. We believe that the education provided to staff and residents or resident representatives will be identical or virtually the same. There do not appear to be data on number of staff at these facilities, but based on the nature of the services provided it appears likely that the staff to client ratio is similar to that in other congregate settings (group homes, assisted living facilities), and likely to be about three-fourths of the client population, or about 75,000 full-time equivalent staff, with similar turnover patterns as well. Also, there have been at least 569,502 total LTC staff COVID-19 confirmed cases and 1,888 total LTC staff COVID-19 confirmed deaths, on a cumulative basis. CMS has waived the requirements at 483.430(c)(4), which requires the facility to provide sufficient Direct Support Staff (DSS) so that Direct Care Staff (DCS) are not required to perform support services that interfere with direct client care. The QALY and VSLY amounts used in any estimate of overall benefits are not meant to be precise, but instead are rough statistical measures that allow an overall estimate of benefits expressed in dollars. We acknowledge the diversity and complexity of the needs of congregate living facilities. L. 79-404), 5 U.S.C. Open for Comment. Accessed on February 17, 2021. Its about getting people vaccinated, to protect them and those around them wherever they go. Requiring all ICFs-IID to report to NHSN would create a new field of administrative burden for ICFs-IID, potentially requiring new equipment, administrative staff, and training. For each LTC facility, we estimate that the burden for this activity would be 6 hours at an estimated cost of $246 ($41 12 .5). Sign up to get the latest information about your choice of CMS topics in your inbox. Updates to CDC's COVID-19 Vaccination Program Provider Agreement Requirements can be located on CDC's website.[40]. For all 5,772 ICFs-IID so the burden for all facilities would be 75,036 burden hours (13 hours 5,772 facilities) at an estimated cost of $5,027,412 (5,772 hours $871). and Medicare will cover the cost of these vaccines. Taken together, these estimates for both residents and staff suggest that total counseling and education efforts would be made for perhaps 849,000 persons after the rule is issued, two-thirds residents and one-third staff. Updated March 16, 2021. Buckle up. Providers who fail to quickly comply with a forthcoming federal staff vaccine mandate likely won't be stripped immediately of their Medicare and Medicaid program eligibility, Centers for. 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. As the Pharmacy Partnership for LTC program comes to an end, it is important to ensure facilities have policies and procedures to provide continued access to COVID-19 vaccine for new or unvaccinated residents and staff, groups that will each exceed in magnitude over the course of this year a number larger than those offered vaccination during the Partnership's tenure. For purposes of this requirement, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. Explaining the risks and benefits of any treatments to a client or representative in a way that they understand is the standard of care. The third major cost component is the vaccination, including both administration and the vaccine itself. If other benefits or risks or possible side-effects are identified in Start Printed Page 26315the future, whether through research, or authorization or licensing of new COVID-19 vaccines, those facts should be incorporated into education efforts. 553 requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. 49. documents in the last year, 153 We estimate that the burden to the LTC facilities will be similar in subsequent years due to the large turnover in these facilities. However, section 1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect before 30 days if the Secretary finds that a waiver of the 30-day period is necessary to comply with statutory requirements or that the 30-day delay would be contrary to the public interest. (viii) The COVID-19 vaccine status of residents and staff, including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID-19 vaccine received, and COVID-19 vaccination adverse events; and. We anticipate that the additional reporting burden to LTC facilities will be minimal. [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. For all LTC facilities, the burden would be 405,600 hours (26 15,600) at an estimated cost of $27,175,200 ($1,742 15,600) annually. Information about this document as published in the Federal Register. CDC has posted Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States describing these clinical situations. As intended under these requirements, this RIA's estimates cover only those costs and benefits that are likely to be the effects of this rule. Any vaccine that receives Food and Drug Administration (FDA) authorization, through an EUA, or is licensed under a Biologics License Application (BLA), will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. In 1970, Congress authorized the secretary of labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce, having found that personal injuries and illnesses arising out of work situations impose a substantial burden in terms of lost production, wage loss, medical expenses, and disability compensation payments. The Occupational Safety and Health Administration (OSHA) is the part of the Labor Department charged with protecting worker safety and health, by developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems in areas including sanitation, air contaminants, hazardous materials, fire protection, and personal protective equipment. CMS accelerated outreach and assistance efforts encouraging individuals working in health care to get vaccinated following the Administrations announcement that it would expand the requirement for staff vaccination beyond nursing homes to include additional providers and suppliers. There are many unknowns (for example, whether vaccine protection lasts only one year rather than 3 years or more, and the possibility of variants that reduce the effectiveness of currently approved vaccines) and we cannot estimate the effects of each of the possible interactions among them, but throughout the analysis we point out some of the most important assumptions we have made and the possible effects of alternatives to those assumptions.Start Printed Page 26328, This rule presents additional difficulties in estimating both costs and benefits due primarily to the fact that an unknown but significant fraction of current LTC staff and residents have already received an explanation of the benefits of vaccination to persons who are elderly or high risk from specific health conditions or both, and the rarely serious risks associated with vaccination (for example, the statistically negligible risk of severe allergic reactions to the vaccine). Given the new and emerging qualities of COVID-19 disease, vaccines, and treatments we recognize that education of clients and staff is critical. CMSs goal is to bring health care providers into compliance. Further, we expect personnel records for facility staff and health records for residents and clients to reflect appropriate administration of any multi-dose vaccine series, including efforts to acquire subsequent doses as necessary. There is some overlap between these two populations and the same person may be admitted on more than one occasion. If the Court uses some version of this concept to constrain Congresss constitutional authority to delegate lawmaking power to agencies, it would at the same time be aggrandizing its own authority to oversee Congresss worka function established in 1803s Marbury v. Madison that is hardly self-evident in the Constitutions text. Because of these issues, they may be less capable of self-care, including arranging for preventive health care. While we are not requiring participation, we encourage individual residents, clients, and staff who use smartphones to use CDC's new smartphone-based tool called v-safe After Vaccination Health Checker (v-safe) to self-report on one's health after receiving a COVID-19 vaccine. Only share your Medicare Number with your provider when you get COVID-related services. 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). Medicare covers the updated COVID-19 vaccine at no cost to you. We estimate that the burden to the LTC facilities will be similar in subsequent years due to the large turnover in these facilities. Social Security Act. At 483.70(i)(1), in accordance with accepted professional standards and practices, the LTC facility must maintain medical records on each resident that are complete and accurately documented. That said, resident turnover within a year may be significant, possibly up to 40 percent based on internal CMS estimates. Of the approximately 540,000 Americans estimated to have died from COVID-19 through March 2021,[72] Accessed on January 26, 2021. Due to prior legal challenges, the actual Phase 1 and Phase 2 deadlines vary from state-to-state. [48] Sound harsh? While LTC facility staff may not have personal medical records on file with the employing LTC facility, all staff COVID-19 vaccinations must be appropriately documented by the facility in a manner that enables the facility to report in accordance with this rule (that is, in a facility immunization record, personnel files, health information files, or other relevant document). (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. The updated Moderna vaccine is available for people 6 and older. (C) If the client did not receive the COVID-19 vaccine due to medical contraindications or refusal. Most LTC facilities participated in the Pharmacy Partnerships but the Partnerships concluded in March 2021. See Centers for Disease Control and Prevention. For the RN, we estimate that this would require 5 hours initially, and 30 minutes or .5 hour a month thereafter to review for updated information to determine if any changes need to be made to the policies or procedures and then make any necessary changes. For the ICF-IID administrator, we believe it would require 3 hours to work with the RN in developing the policies and procedures and give final approval before taking the policies and procedures to the governing body for approval. CDC has information describing IPC considerations for residents of ICF-IIDs with systemic signs and symptoms following COVID-19 vaccination. The second and third sections of Table 5 show how these numbers are split between residents and staff, and LTC facilities and ICFs-IID, respectively. Among those age 65 years or above, or with severe risk factors, as many as 40 percent of those known to be infected required hospitalization in the first month of the pandemic. For these persons, the average age is about 50, which creates two offsetting effects: They have more years of life expectancy than residents, but their risk of from COVID-19 death is far lower. In accordance with the Social Security Act, medical facilities that receive Medicaid or Medicare funding, including hospitals, skilled-nursing facilities, and hospices, must enter into an agreement with HHS and meet specified conditions of participationsuch as vowing not to discriminate against eligible patients, allowing unannounced on-site inspections, and furnishing fingerprint-based criminal-background checks on request. Facilities should establish policies and procedures for evaluating and documenting exemptions. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. This toolkit provides LTC administrators and clinical leadership with information and resources to help build vaccine confidence among residents, clients, and staff. While these estimates give the appearance of precision since they present costs to the nearest thousand dollars, this is simply the result of calculations based on numerical assumptions. Because COVID-19 is contagious, and thus unvaccinated employees can pose a threat to coworkers and customers, the focus of inquiry in most instances will be on whether a reasonable accommodation was offered rather than on the direct-threat requirement. The power of a federal health agency to make critical decisions could hang on whether the U.S. Supreme Court allows the Biden administration to enforce its vaccine mandate for health-care workers while lawsuits unfold. 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. Accessed on March 23, 2021. Before sharing sensitive information, make sure youre on a federal government site. and the impetus of the Supreme Court's Olmstead decision. 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. A FAIR Health study examined the relationship between preexisting comorbidities of COVID-19 and mortality in privately insured individuals as reported in a white paper, Risk Factors for COVID-19 Mortality among Privately Insured Patients: A Claims Data Analysis. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (Expiration Date 06/30/2022). Therefore, this activity is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). The updated Pfizer vaccine is available for people 5 and older. The Supreme Court has long upheld agencies regulatory power and, indeed, demanded judicial deference to it, in part based on the rationale that the 535 members of Congress dont collectively have the broad and complex expertise required to address all of the countrys legislative needs, and that unelected judges should not be the ones who fill in legislative blanks. Specifically, QIOs may provide assistance to LTC facilities by targeting small, low performing, and rural nursing homes most in need of assistance, and those that have low COVID-19 vaccination rates; disseminating accurate information related to access to COVID-19 vaccines to facilities; educating residents and staff on the benefits of COVID-19 vaccination; understanding nursing home leadership perspectives and assist them in developing a plan to increase COVID-19 vaccination rates among residents and staff; and assisting providers with reporting vaccinations accurately. For the same reasons, because we cannot afford sizable delay in effectuating this IFC, we find good cause to waive the 30-day delay in the effective date and, moreover, to make this IFC effective 10 calendar days after this rule is filed for public inspection in the Federal Register. 7500 Security Boulevard, Baltimore, MD 21244, Medicare covers items & services related to COVID-19, Be alert for scammers trying to steal your Medicare Number, FDA-authorized and FDA-approved COVID-19 vaccines, FDA-authorized COVID-19 antibody (or serology) tests, Monoclonal antibody treatments for COVID-19, Find a Medicare Supplement Insurance (Medigap) policy.