43. This rule does contain mandates on private sector entities, and we estimate the resulting amount to be about the same as this threshold in the first year. The CMS Nursing Home COVID-19 training program has five modules designed for the frontline clinical staff and ten modules for nursing home management staff (building maintenance staff and other support staff would not take these particular courses). As established by this rule at 483.80(d)(3), LTC facilities are not required to educate and offer vaccination to individuals who provide services less frequently, but they may choose to extend such efforts to them. And yet not far enough. 24/7 coverage of breaking news and live events. But some contend its time to stop now, citing fewer severe COVID-19 cases, health care staffing shortages and the impending May 11 expiration of a national public health emergency that has been in place since January 2020. 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. 99. See, for example, news stories: https://www.abc27.com/news/health/coronavirus/official-biden-moving-vaccine-eligibility-date-to-april-19/. ICRs Regarding the Development of Policies and Procedures for 483.460(a)(4), 2. has no substantive legal effect. For subsequent years, the IP would need to review the policies and procedures and make any updates or changes to them. In commenting, please refer to file code CMS-3414-IFC. Assuming that the efforts to educate residents, clients, and staff succeed in raising the vaccinated percentage by 5 percent points over the course of the first year, calculated from the 70 percent (staff) to 80 percent (residents and clients) baseline likely to be achieved before this rule takes effect, total vaccination costs across these target groups resulting from this rule would be $23,460,000 ($80 .05 5,865,000). documents in the last year, 84 69. Open for Comment. 7. Thus, for each LTC facility to meet this requirement would require 4 burden hours at an estimated cost of $268 (4 $67). Currently, low rates of voluntary use of NHSN for vaccination reporting precludes accurate estimates of vaccine coverage. 17. Bidens plan is not about protecting people only at work. Because this rule has no direct effects on any hospitals, the Department has determined that this interim final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. Educating staff further about the development of the vaccine, how the vaccine works, and the particulars of multi-dose vaccine series is encouraged but not required. The National Law Review is a free to use, no-log in database of legal and business articles. 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. The variety and prevalence of comorbidities in individuals served that may increase their risk of severe illness from COVID-19. 97. I didnt call for all employers to require vaccines, but I hoped many would and I supported those that did. Find Medicare.gov on facebook (link opens in a new tab), Follow Medicare.gov on Twitter (link opens in a new tab), Find Medicare.gov on YouTube (link opens in a new tab), A federal government website managed and paid for by the U.S. Centers for Medicare and Medicaid Services. Their ability to impose mandates is limited by the Americans with Disabilities Act (ADA) and Title VIIs prohibitions against disability and religious discrimination. We recognize that facilities may choose to use a broader definition of staff. We note that CDC categorizes staff in the NHSN as: Ancillary service employees, nurse employees, aides, assistant and technician employees, therapist employees, physician and licensed independent practitioner employees and other health care providers. CDC, Risk for COVID-19 Infection, Hospitalization, and Death by Age Group, at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-age.html. This would require that a staff person document the required information in the staff person's record. We believe that all of the education provided by the ICF-IID to the client, client's representative and the staff would be virtually identical. 42 U.S.C. 28. 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. We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the provisions of the rule are finalized, either as proposed or as amended in response to public comments, and take effect, in accordance with the Administrative Procedure Act (APA) (Pub. Finally, we also waived, in part, the requirements at 483.430(e)(1) related to routine staff training programs unrelated to the public health emergency. Ashvin Gandhi et al., High Nursing Staff Turnover In Nursing Homes Offers Important Quality Information, Health Affairs, March 2021, pages 384-391. CDC. [84] One of the major benefits of vaccination is that it lowers the cost of treating the disease among those who would otherwise be infected and have serious morbidity consequences. The governments power to mandate vaccines in the face of individual recipients due process and other constitutional objections traces back to the Supreme Courts 1905 decision in Jacobson v. Massachusetts, and it is unlikely to be revisited in these particular cases. Vaccine Mandates and Federal Law. Post-vaccine considerations are listed out for consideration by ICFs-IID clinical staff. But some recover and leave so we have used five years as a reference point. Even if two-thirds of Start Printed Page 26321all newly hired staff and newly admitted residents have been vaccinated when they start employment or begin residency, turnover is so high that we estimate an excess of two million persons may still need vaccination in the first year after this rule takes effect. 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. We received 299 public comments in response to the May 8th COVID-19 IFC. 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. We do not intend to prohibit such extensions and encourage facilities to educate and offer vaccination to these individuals as reasonably feasible. of this rule. For example, the duration of vaccine effectiveness in preventing infection, reducing disease severity, reducing the risk of death, and preventing disease transmission by those vaccinated are all currently unknown. We further assume that employee turnover is 80 percent a year, lower than the results for nurses previously cited. 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). https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm. Finally, this IFC was not preceded by a general notice of proposed rulemaking and the RFA requirement for a final regulatory flexibility analysis does not apply to final rules not preceded by a proposed rule. For the IPs in all 15,600 LTC facilities, the burden would be 327,600 hours (21 hours 15,600 facilities) at an estimated cost of $21,949,200 ($1,407 15,600). 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. 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. Guidance issued recently by CMS, the Department of Health and Human Services Office of Civil Rights, and the Safer Federal Workforce Program, combined with earlier guidance from the Office of Economic Opportunity, provide some direction through this thicket of federal requirements. This table of contents is a navigational tool, processed from the We note that until that time, individuals may request data per the Freedom of Information Act (FOIA) (5 U.S.C. 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. This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as nursing homes) and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. LTC facility staff are integral to the function of LTC facilities and the health and well-being of residents. All LTC facilities are already required, at 483.80(g), to report certain COVID-19 case and outcomes data to NHSN every week, and the new vaccination reporting is in the same NHSN reporting system they currently use. 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. The second IFC was the 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 interim final rule with comment, which appeared in the September 2, 2020 Federal Register (85 FR 54820) with an effective date of September 2, 2020 (hereafter referred to as the September 2nd COVID-19 IFC). Vaccine availability may vary based on location, and vaccination and medical staff authorized to administer the vaccination may not be readily available onsite at many congregate living or residential care settings. Sorting out all these factors to reach either a qualitative or quantitative estimate of net benefits from any particular policy is extremely complex and is one reason why vaccination priorities have differed among the states and over time. The Rule requires health care providers to establish a process or policy to fulfill the staff vaccination requirements over two phases: Phase 1: Requires staff at all health care facilities covered by the regulation to have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to staff providing care, treatment or other services for the facility and/or its patients. Texas, which has the most nursing homes nationally participating in Medicare or Medicaid, had just one nursing home cited for violating the vaccination rule. We anticipate that the additional reporting burden to LTC facilities will be minimal. 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. Condition of participation: Facility staffing. By continuing on our website, you agree to our use of the cookie for statistical and personalization purpose. Vaccine and vaccination costs are generally paid by the Federal Government. 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 . Jason A. Levine, Ryan Martin-Patterson, and Stephen TagertOVERVIEWThe top developments in COVID-19 litigation since our last post include: court action on federal vaccine mandate challenges, including oral argument in the Supreme Court; a purported whistleblower complaint against Moderna concerning supposedly inaccurate public disclosures about its patents; Pfizer's settlement of a patent . 11-9111 Medical and Health Services Managers. Only share your Medicare Number with your provider when you get COVID-related services. The requirements and burden will be submitted to OMB under OMB control number 0938-New. If other benefits, risks, or side-effects are identified in the future, whether through research, or authorization or licensing of new COVID-19 vaccine products, those facts should be incorporated into education efforts. No more postponements. FDA's EUA website includes letters of authorization and fact sheets and these should be checked for any updates that may occur. Biden orders sweeping new vaccine mandate affecting 100M Americans . https://www.cdc.gov/vaccines/covid-19/long-term-care/pharmacy-partnerships.html and provide additional information on vaccination under this program: https://covid.cdc.gov/covid-data-tracker/#vaccinations-ltc. The information reported to CDC in accordance with 483.80(g) will be shared with CMS and we will retain and publicly report this information to support protecting the health and safety of residents, staff, and the general public, in accordance with sections 1819(d)(3)(B) and 1919(d)(3) of the Act. By far the largest source of data related to ICF and other IID services is In-Home and Residential Long-Term Supports and Services for Persons with Intellectual or Developmental Disabilities: Status and Trends 2017, at https://ici-s.umn.edu/files/aCHyYaFjMi/risp_2017. 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. [1] ICRs Regarding Staff Education Requirements in 483.80(d)(3)(ii) Through (iv), 4. documents in the last year, 9 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. Updated January 5, 2021. 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. For this IFC, we believe it would be impractical and contrary to the public interest for us to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. The virus has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the disease it causes has been named coronavirus disease 2019 (COVID-19). If an additional dose of the COVID-19 vaccine that was administered, a booster, or any other vaccine needs to be administered, the client, client representative, and staff member must be provided with the current information regarding the benefits and risks and potential side effects for that vaccine, before the ICF-IID requests consent for administration of that dose. While most residents in LTC facilities are isolated from the broader community during the PHE, staff travel to and from the facility and the community, presenting risks of transmitting the virus to or from residents, family members, other caregivers, and the public. For example, the website currently has Long-Term Care Facility Toolkit: Preparing for COVID-19 in LTC facilities[38] CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. During the PHE, some facilities have struggled to retain staff and, as noted above, some staff working in these facilities may also have more than one job that puts them at higher risk. If you have other coverage like a Medicare Advantage Plan, review your Explanation of Benefits. Report anything suspicious to your insurer. Specifically, before offering the COVID-19 vaccine, all staff members and residents or resident representatives must be provided with education regarding the benefits and risks and potential side effects associated with the vaccine. Accessed on February 17, 2021. 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. See The Long-Term Care COVID Tracker at https://covidtracking.com/nursing-homes-long-term-care-facilities,, and the KFF State COVID-19 Data and Policy Actions at https://www.kff.org/coronavirus-covid-19/issue-brief/state-covid-19-data-and-policy-actions/#longtermcare. 50. 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. require the exercise of legislative power that only Congress can perform. Justice Samuel Alito has similarly emphasized that the principle that Congress cannot delegate away its vested powers exists to protect liberty. And Justice Brett Kavanaugh has quietly endorsed Justice Neil Gorsuchs opinion that Congress cannot delegate to agencies the authority to decide major policy questionseven if Congress expressly and specifically delegates that authority.. Declining infection rates in LTC facilities in early 2021 suggest that vaccination, along with implementation of the full complement of non-pharmaceutical interventions, including engineering and administrative controls, has reduced the risk of illness and death from COVID-19 for LTC facility residents. In 1965, Congress charged an executive-branch agencythe Department of Health, Education, and Welfare (renamed the Department of Health and Human Services, or HHS, in 1979)with the task of implementing the Medicare and Medicaid programs. Long-term residents are a major group within nursing homes and are generally in the nursing home because their needs are more substantial and they need assistance with the activities of daily living, such as cooking, bathing, and dressing. At 483.80(d)(3)(iii), we require that LTC facilities provide their residents or resident representatives with education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine. Explaining the risks and possible side effects and benefits of any treatments to a resident or their representative in a way that they can understand is the standard of care, and a patient right as specified at 483.10(c)(5). In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) requires that we solicit comment on the following issues: We are soliciting public comments on each of these issues for the following sections of this document that contain information collection requirements (ICRs): For the estimated costs contained in the analysis below, we used data from the United States Bureau of Labor Statistics to determine the mean hourly wage for the positions used in this analysis. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. 46. [53] We also require LTC facilities to offer education on influenza and pneumococcal vaccines and to give the resident or the resident representative the opportunity to accept or refuse vaccine. 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. Under certain state laws the following statements may be required on this website and we have included them in order to be in full compliance with these rules. While the Pharmacy Partnerships have had much success in ensuring timely vaccine access to many LTC facility residents and staff, we note that not all such individuals were able to receive vaccine under the program. 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. You can get the updated vaccine at least 2 months after completing your primary vaccination series (2 doses of Pfizer-BioNTech, Moderna, or Novavax, or one dose of Johnson & Johnson)regardless of how many original COVID-19 vaccines you got so far. Aggregate COVID-19 vaccination data collected as a result of this rulemaking will be made available to the public in the future. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. The burden for each LTC facility would be 12 hours at an estimated cost of $804 (12 hours $67) for the IP. Likewise, we are revising the ICF-IID Conditions of Participation to require that facilities must educate all clients and staff about COVID-19 vaccines and offer vaccination to all clients and staff. 89. We believe that this activity would require that the IP routinely review CDC and FDA websites for updates and make any necessary changes to the education materials used by the LTC facility. CDC has recommended states place LTC facility residents and health care personnel into Phase 1a. Supporting Vaccine Distribution and Uptake, C. Data for COVID-19 Vaccine Reporting: Targeting Resources, IV. Its not clear how many of those people are unvaccinated. Check with your plan to see if it will cover and pay for these tests. Read: The nonsensical loophole in Bidens vaccine mandate, A similar delegation of power to the executive branch is what enabled Bidens vaccine-or-test mandate for businesses with 100 or more employees. (2) Staff were offered COVID-19 vaccine or information on obtaining the COVID-19 vaccine. After May 11, 2023: Keep reading to learn more about these changes. You may submit electronic comments on this regulation to http://www.regulations.gov. The COVID-19 vaccine education will build upon that knowledge. Since the publication of the September IFC, the FDA has issued EUAs for multiple vaccines developed to prevent the spread of SARS-CoV-2. In about half of these, the court has refused to block the mandate or dismissed the case. Only the healthy are allowed in to care for virus-free residents. 29-1228 Physicians, All Other; and Ophthalmologists, Except Pediatric. 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). Given the new and emerging qualities of COVID-19 disease, vaccines, and treatments we recognize that education of clients and staff is critical. We welcome suggestions on how the regulations should be revised to ensure that congregate living within our regulatory authority are able to reduce the spread of SARS-CoV-2 infections. Education and vaccine administration must be reflected in facility policies and procedures, as well as in staff and resident records. 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. On January 13, 2022, the Supreme Court weighed in on these challenges, ultimately upholding the Rule. As for the recipients of such education, we assume that about three-fourths of them are residents, and one-fourth staff. Staff education must cover the benefits and risks or possible side effects of vaccination, which typically include reduced risk of COVID-19 illness, and related serious COVID outcomes, including hospitalization and death, the bolstered protection offered by completing a full series of multi-dose vaccines (if used), and other benefits identified as research and immunization continues. publication in the future. Ideology or Antitrust? Though nursing homes can be fined for violations, CMS generally gave violating facilities additional time to update their policies and come into compliance. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (Expiration Date 06/30/2022). documents in the last year, 669 Occupational Employment and Wages, May 2019. documents in the last year, 422 Updates to CDC's COVID-19 Vaccination Program Provider Agreement Requirements can be located on CDC's website.[40]. Ensuring workplace and patient safety is critical, but so is making sure Medicare and Medicaid recipients have access to the care they need. Therefore, we find there is good cause to waive the delay in effective date pursuant to the APA, 5 U.S.C. Biden-Harris Administration Issues Emergency Regulation Requiring - CMS As previously discussed, we do not have current reporting data on facility compliance with COVID-19 vaccination best practices of the kinds established in this rule. 808(2). Before sharing sensitive information, make sure youre on a federal government site. CMS recognizes the gravity of the current public health emergency and the importance of facilitating availability of vaccines to prevent COVID-19. Secretary, Department of Health and Human Services. Nothing in the actual text of Article I distinguishes between major policy questions that Congress cannot hand off to agencies and, in Kavanaughs words, less-major or fill-up-the-details decisions for which Congress, in his view, can invoke agency support. Similar requirements for large employers, military members and federal contractors all have been struck down, repealed or partially blocked. Only official editions of the Finally, health departments for states, the District of Columbia, and territories all have access to NHSN data for their jurisdictions and can use these data to inform their own response efforts. Nonetheless, the tea leaves suggest that the administrative bureaucracy is in for an overhaul with this Supreme Court majority. Unfortunately, we have significant data gaps about the effects of COVID-19 and vaccination rates among ICF-IID clients, with fewer than 80 ICFs-IID voluntarily reporting vaccination data through NHSN. Which is why the vaccine-mandate cases are such a huge deal. Facility influenza vaccine data are available through CMS's Care Compare tool because these data are collected directly through the MDS, which feeds into the Care Compare tool. For each ICF-IID it would require 3 hours annually (0.25 12) at an estimated cost of $123 ($41 3 hours). They may also provide it indirectly, such as through arrangement with a pharmacy partner or local health department.

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