vaccine mandate for medicare recipients

Consistent vaccination reporting by LTC facilities via the NHSN will help to identify LTC facilities that have potential issues with vaccine confidence or slow uptake among either residents or staff or both. NHSN data will allow CDC to determine the number and percentage of staff and residents in each facility who have received the COVID-19 vaccine.[50]. ICF-IID staff are integral to the function of the ICFs-IID and the health and well-being of clients. Though most other health care sectors have rebounded, nursing home employment was down 13% in 2022 comparedto pre-pandemic levels and reached lows not seen since the 1990s. 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. 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. 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/. HCBS is an umbrella term for long term services and supports that are provided to people in their own homes or communities rather than institutions or other isolated settings. We note that the LTC facility or the pharmacy would also have to offer the vaccine to the staff member or resident and have that staff member, resident, or resident representative, complete screening for any contraindication or precautions, and for the resident to consent to the vaccination or indicate refusal. 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. 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. Today, more than 2,500 hospitals, or 40 percent of all U.S. hospitals, have announced COVID vaccination requirements for their workforce. . Federal Register. The emergency regulation issued by the Centers for Medicare & Medicaid Services (CMS) today protects those fighting this virus on the front lines while also delivering assurances to individuals and their families that they will be protected when seeking care. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [78] The OFR/GPO partnership is committed to presenting accurate and reliable The updated vaccine targets the original COVID-19 viral strain and 2 Omicron variants (BA.4/BA.5). But I dont believe in government requirements on private employers. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. A growing number of states have enacted legislation directed at employer vaccine mandates. initially declined the vaccine, but provisional CDC data suggest that uptake increased over time as the safety and effectiveness of the vaccines has become better understood, and approaches that ameliorate vaccine hesitancy have been identified. https://www.ada.gov/olmstead/S. This could be the start of a major dismantling of the federal government. We note that at this time, some LTC facility residents and ICF-IID clients may not be eligible to receive vaccination due to age (that is, they are younger than 16), but we anticipate that they may become eligible for vaccination if authorized use of COVID-19 vaccines is expanded in the future. [7071] Finally, we expect that trade publications and other public sources would provide training materials. Individualized counseling, resident meetings, staff meetings, posters, bulletin boards, and e-newsletters are all approaches that can be used to provide education. While we require that all residents and staff must be educated about the vaccine, we note that in situations, for example, where an individual has already received a Start Printed Page 26313COVID-19 vaccine or has a known medical contraindication (that is, an allergy to vaccine ingredients or previous severe reaction to a vaccine), the facility is not required to offer vaccination to that person. 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. 53. These markup elements allow the user to see how the document follows the Some congregate living residents require close assistance and support from facility staff, which further reduces their ability to maintain physical distance. Facilities can determine where they keep the documentation that demonstrates educational efforts and offering the vaccine to staff. Screening individuals for currently suspected or confirmed cases of COVID-19, previous allergic reactions, and administration of therapeutic treatments and services is important for determining whether these individuals are appropriate candidates for vaccination at any given time. Corbin said the outbreak originated from an unvaccinated employee with a religious exemption who tested negative for COVID-19 before working a shift and wore a mask. Federal law permits, and in some situations requires, employers to ensure that their employees are vaccinated against COVID-19. In our analysis of first-year benefits of this rule we focus on prevention of death among residents of LTC facilities and ICFs-IID, as well as on progress in reducing disease severity. In addition, LTC facilities must also report any COVID-19 therapeutics administered to residents. 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. *Beginning of Year is roughly identical to average for year when population is stable. At 483.80(d)(3)(vi), we require that the facility ensure that the resident's medical record is documented with, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential risks associated with the COVID-19 vaccine and that the resident either received the COVID-19 vaccine, did not receive the vaccine due to medical contraindications, or refused the vaccine. 11-9111 Medical and Health Services Managers. People living and working in these living situations may have challenges with social distancing and other mitigation measures, like mask use and handwashing, that help to prevent the spread of SARS-CoV-2. CMS cited substantial compliance with the vaccination requirement while making the change. https://www.cdc.gov/coronavirus/2019-ncov/community/group-homes.html. Wendy E. Parmet: Americans are suing to protect their freedom from infection. Not only does it protect the health care worker themself, but it also protects the patients.. Internal CDC data shows that 99 percent of participating SNFs had held their 3rd (final) clinic as of March 15, 2021. COVID-19 Disease and Vaccine Education, b. LTC Facility Residents and Resident Representatives, B. This reporting of therapeutics requirement is similar to the requirement that hospitals must report information about therapeutics (85 FR 85866). See https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor/. There are also individuals who may enter the facility for specific purposes and for a limited amount of time, such as delivery and repair personnel, or volunteers who may enter the ICF-IID Start Printed Page 26318infrequently (meaning less than once weekly). But the federal Centers for Medicare & Medicaid Services does not scrutinize the rationale for such exemptions. The number of individuals residing in large public ICFs-IID has decreased steadily over time (from 55,000 total residents in 1997 to approximately 16,000 as of April 2021). All state health departments and many local health departments already have direct access through NHSN to LTC facilities' COVID-19 data and are using the data for their own local response efforts. Section 483.460 is amended by redesignating paragraph (a)(4) as paragraph (a)(5) and adding new paragraph (a)(4) to read as follows: (4) The intermediate care facility for individuals with intellectual disabilities (ICF/IID) must develop and implement policies and procedures to ensure all of the following: (i) When COVID-19 vaccine is available to the facility, each client and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated or the client or staff member has already been immunized. The EUA fact sheet explains the risks or potential side effects and benefits of the COVID-19 vaccine they are receiving and what to expect. The regulation will create a consistent standard within Medicare and Medicaid while giving patients assurance of the vaccination status of those delivering care. At new 483.460(a)(4), we require that ICFs-IID develop policies and procedures to ensure that each client or client's representative and staff member is educated about the COVID-19 vaccine. 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. We believe the IP would do this weekly reporting to the NHSN, because this reporting would require information on the therapeutics that were administered to resident for treatment of COVID-19. 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. CDC advises that COVID-19 vaccination providers should document vaccine administration in their medical records within 24 hours of administration and report administration data as specified in their vaccine provider agreements and to applicable local vaccine tracking programs (that is, Immunization Information System). L. 79-404), 5 U.S.C. The requirements and burden will be submitted to OMB under OMB control number 0938-1363 (Expiration Date 6/30/2022). documents in the last year, 887 In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority. For example, when the Pharmacy Partnership completes its time commitment, it is likely that it will have seen only about half of the persons who will reside or work in these facilities in 2021. According to Table 1 above, the total hourly cost of a financial clerk is $41. In addition to facility-employed personnel, many facilities have services provided on-site, on a regular basis by individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, or volunteers. The EUA allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S. FDA has now issued EUAs for three vaccines for the prevention of COVID-19, to Pfizer (December 11, 2020) (16 years of age and older), Moderna (December 18, 2020) (18 years of age and older), and Johnson & Johnson's Janssen (February 27, 2021) (18 years of age and older). On November 5, 2021, the Secretary of Health and Human Services issued an Interim Final Rule that amended the conditions of participation in Medicare and Medicaid to require certain providers and suppliers to ensure their covered staff are vaccinated against COVID-19 (Rule). 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. The reason the facility was cited for a vaccination deficiency was because three employees had failed to receive their second dose of the vaccine and had no exemption on record. 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. Table 2Total Cost for COI Requirements for All LTC Facilities. ICF-IID clients continue to be at high risk of serious illness from COVID-19 due to their participation in congregate living and must have ongoing access to the vaccine. For those same reasons, we find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under the APA, 5 U.S.C. While there would be great value in collecting more data about COVID-19 incidence and vaccinations in ICFs-IID, we are not mandating such data submission at this time. 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. 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. Accessed at https://vaers.hhs.gov/. There may be posters and flyers announcing appointments for vaccine clinic days or other opportunities to be vaccinated. It is important to talk to residents and representatives to learn why they may be declining vaccination on their own behalf, or on behalf of the resident, and tailor any educational messages accordingly. On March 13, 2020, the President declared the COVID-19 pandemic a national emergency. 43. 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]. . Medicare wants to help protect you from COVID-19: Military hospital ships and temporary military hospitals dont charge Medicare or civilians for care. 90. 75. How are they structured and what challenges have you faced with regard to implementation? Conditions of participation: Health care services. They span all 50 states, the District of Columbia, and Puerto Rico. documents in the last year, 1471 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. Finally, the resident's medical record includes documentation that indicates, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential risk associated with the COVID-19 vaccine, and that the resident either received the complete COVID-19 vaccine (series or single dose) or did not receive the vaccine due to medical contraindications or refusal. 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. The infection prevention and control plan is designed to allow for documentation of vaccine efforts. NLR does not answer legal questions nor will we refer you to an attorney or other professional if you request such information from us. Many states have either closed a significant number of these facilities completely or downsized them through rebalancing efforts,[7] 82. Internal CDC data shows that 99 percent of participating SNFs had held their third (final) clinic as of March 15, 2021. (C) If the client did not receive the COVID-19 vaccine due to medical contraindications or refusal. 57. 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. For the purposes of COVID-19 vaccine education and offering, we consider ICF-IID staff to be those individuals who work in the facility on a regular (that is, at least once a week) basis. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html. 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. States and individual health systems have historically addressed vaccination requirements for diseases such as influenza and hepatitis B. CDC further notes that congregate living facilities may choose to vaccinate residents and clients at the same time as staff, because of shared increased risk of disease.[4]. We believe that developing these policies and procedures would require a RN to gather the necessary information and materials and draft the policies and procedures. We further assume that 20 percent of these are new residents each year who must be offered vaccination (most are already vaccinated, as discussed later in the analysis). If you get other medical services at the same time you get the COVID-19 vaccine, you may owe a copayment or deductible for those services. of the issuing agency. The EUA fact sheet explains the risks and possible side effects and benefits of the COVID-19 vaccine they are receiving and what to expect. 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). Once again, its fair to say that the political rights mantra of judicial conservatism may soon stop at the courthouse doors of this Supreme Court. They may also provide it indirectly, such as through arrangement with a pharmacy partner or local health department. We request public comment on whether states are collecting COVID-19 vaccination data already, through other mechanisms. Ensuring that LTC residents, ICF-IID clients, and staff have the opportunity to receive COVID-19 vaccinations will help save lives and prevent serious illness and death. We note that this includes those individuals who may not be physically in the ICF-IID for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. The Provider Relief Fund Uninsured Program will also reimburse for administration of COVID-19 vaccine to individuals who are uninsured.[47]. About 40 federal lawsuits have been filed challenging employer or government vaccine mandates. 98. Box 8010, Baltimore, MD 21244-1850. For education of staff, we make similar assumptions, except that early and anecdotal evidence suggests that a third or more are declining vaccination. The NLR does not wish, nor does it intend, to solicit the business of anyone or to refer anyone to an attorney or other professional. 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. 73. We estimate that it would take an average of 4 hours for the IP to accomplish these tasks. There is some overlap between these two populations and the same person may be admitted on more than one occasion. 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. Sound harsh? 05/01/2023, 258 We recognize that facilities may choose to use a broader definition of staff. We note that CDC defines staff in the NHSN as: Ancillary service employees, nurse employees, aide, assistant and technician employees, therapist employees, physician and licensed independent practitioner employees and other health care providers. 60. 41. Inequities have persisted through the COVID-19 PHE, with racial and ethnic minorities continuing to have higher rates of infection and mortality. offers a preview of documents scheduled to appear in the next day's Documentation regarding a resident's medical care is a usual and customary business practice for a health care provider. CDC has information describing IPC considerations for residents of ICF-IIDs with systemic signs and symptoms following COVID-19 vaccination. https://www.cdc.gov/vaccines/pandemic-guidance/index.html. They are in charge of their workplaces, and the law is on their side should they choose to mandate vaccines. While we require that all clients and staff must be educated about the vaccine, we note that in situations where an individual has already received the vaccine or has a known medical contraindication (that is, an allergy to vaccine ingredients or previous severe reaction to a vaccine), the facility is not required to offer vaccination to that person.[52]. Ensuring the health and safety of all Americans, including Medicare and Medicaid beneficiaries, and health care workers is of primary importance. For the total hourly cost, we doubled the mean hourly wage for a 100 percent increase to cover overhead and fringe benefits, according to standard HHS estimating procedures. CMS continues to encourage individuals not to submit duplicative comments. https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Its about getting people vaccinated, to protect them and those around them wherever they go. We live in the world that flowed from that shift in legal doctrine: Executive-branch agencies dot Washington, D.C., and the thousands of rules and regulations they issue each yearwhich by the end of 2021 numbered 19 for every one law passed by Congresscontrol countless aspects of American life and the economy. The policy requires workers, contractors and volunteers at facilities receiving Medicare or Medicaid payments to have the full primary dosage of an original COVID-19 vaccine, with exemptions for medical or religious reasons. We estimate that it would initially require 7 hours and thereafter 6 hours annually to review for updates and make those changes to the educational materials for a total of 13 hours for the RN to accomplish these tasks in the first year. On March 11, 2020, the WHO publicly declared COVID-19 a pandemic. I suspect some employers silently welcomed Bidens mandate. Re-vaccination or use of new and improved vaccines would likely maintain the effectiveness of vaccination for residents and staff. A major caution about these estimates: None of the sources of enrollment information for these programs regularly collect and publish information on client or staff turnover during the course of a year. On March 2, 2021, CDC issued Interim Considerations for Phased Implementation of COVID-19 Vaccination and Sub-Prioritization Among Recommended Populations, which notes that increased rates of transmission have been observed in these settings, and that jurisdictions may choose to prioritize vaccination of persons living in congregate settings based on local, state, tribal, or territorial epidemiology. The LTC Facility Toolkit: Preparing for COVID-19 Vaccination at Your Facility has information and resources to build confidence among staff and residents. The estimate that 53 percent of these LTC facility and ICF-IID populations as of the end of March were actually vaccinated is simply a weighted average of these numbers. 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. 64. It is critically important that facilities are required to continue to offer vaccination to their residents and staff on an ongoing basis. 801(a)(3). documents in the last year, 24 This IFC directly supports that goal by requiring education about and offer of COVID-19 vaccination for LTC facility and ICF-IID residents, clients, and staff. Medicare covers COVID-19 tests you get from a laboratory, pharmacy, doctor, or hospital, and when a doctor or other authorized health care professional orders it. documents in the last year, 153 These facilities serve over 64,812 individuals with intellectual disabilities and other related conditions. This figure implicitly assumes that a much higher take-up rate was achieved during the first three months of 2021, likely about 80 to 90 percent of all those residents reached by Pharmacy Partners and other early vaccination efforts, and that there will be more and more varied effort needed for the remainder, most of whom presumably declined the initial offer. https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094. 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. About 161, or over one-half of those comments, addressed the requirement for COVID-19 reporting for LTC facilities set forth at 483.80(g). 11, pp. I wrote then that while I believe it is wise for everyone to get the shots, forcing it on workers would be the wrong way to handle the situation.

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