vaccine mandate for medicare recipients
ICF-IID clients with certain underlying medical or psychiatric conditions may be at increased risk of serious illness from COVID-19. Thus, we expect that this required education would be in a language that the resident or the resident representative understands. The Federal Government has also launched the Federal Retail Pharmacy Program, a collaboration between the Federal Government, states, and territories, and 21 national pharmacy partners and independent pharmacy networks representing over 40,000 pharmacies nationwide, including LTC facility pharmacy locations. Each manufacturer is also developing educational and training resources for its individual vaccine candidate. 62. Has your State or county included residential and adult day health or day habilitation staff on the vaccine-eligible list as health care providers? daily Federal Register on FederalRegister.gov will remain an unofficial Further, such mandatory reporting allows health care agencies and regulators to better evaluate the impact and importance of vaccination. This interim final rule with comment is one step in the broad effort to support those individuals at higher risk, in part because of living or working arrangements. We estimate that the average cost of a vaccination is what the Government pays under Medicare: $20 2 = $40 for two doses of a vaccine, and $20 2 for vaccine administration of two doses, for a total of $80 per resident. Washington President Biden announced Wednesday he is ordering the Department of Health and Human Services (HHS) to require nursing homes to have vaccinated staff for them to be able to. documents in the last year, 19 About 80 million people could be affected by a new rule that employers with more than 100 workers must require immunizations or offer weekly testing. Paul Muschick is a former columnist for The Morning Call. 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. But these objections notwithstanding, for more than 85 years Congress has routinely given agencies the authority to make lawsregulations, technically, but they function as lawsand the Supreme Court has consistently refused to interfere. The low likelihood of severe side effects should be included in this education. Further, FOIA requires that agencies make available for public inspection copies of records, which because of the nature of their subject matter, have become or are likely to become the subject of subsequent requests for substantially the same information. But some contend it's 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. We find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. of this rule, are also seen within LTC facilities. Categories are further broken down into environmental, laundry, maintenance, and dietary services; registered nurses and licensed practical/vocational nurses; certified nursing assistants, nurse aides, medication aides, and medication assistants; therapists (such as respiratory, occupational, physical, speech, and music therapist) 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.[41]. Both the medical director and the DON would need to have meetings with the Start Printed Page 26323IP to discuss the development, evaluation, and approval of the policies and procedures. If a vaccine policy applied to both shared living and day programs for adult day health or day habilitation, for example, who or what entity should have the responsibility for ensuring that all residents and staff have access to COVID-19 vaccination? In addition, LTC facilities must also report any COVID-19 therapeutics administered to residents. 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. 51. While there are large numbers of such record notations to be made, we estimate that they take only a few seconds per record. Nothing in this rule will have a substantial direct effect on state or local governments, preempt state laws, or otherwise have federalism implications. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. See Table 2 below. Updated March 18, 2021. These services are rehabilitative and generally last only days, weeks, or months. Some resident education can take place in group settings and some education will take place on a one-to-one level. An employer may not simply condition eligibility for medical benefits on vaccination. Examples of educational and training topics include engaging residents in effective COVID-19 vaccine conversations, answering questions about consent for vaccine, common side effects, educating residents and staff about what to expect after vaccination, and the importance of maintaining infection prevention and control practices after vaccination. [5], There are currently 5,768 Medicare- and/or Medicaid-certified ICFs-IID, and all 50 States have at least one ICF-IID. At this point in the pandemic, employers should be deciding whats right for their workplace, not the federal government. With this IFC, we are amending the requirements at 483.80 to add new paragraph (d)(3)(ii) to require that LTC facility staff are educated about vaccination against COVID-19. In addition to the topics addressed above for education of ICF-IID staff, education of clients and representatives should cover the fact that, at this time while the U.S. Government is purchasing all COVID-19 vaccine in the Start Printed Page 26319United States for administration through the CDC COVID-19 Vaccination Program, all ICF-IID clients are able to receive the vaccine without any copays or out-of-pocket costs. 6. Until then, the agency is urging healthcare facilities to prepare their workforces for the new rules. 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. [90] See MEDPAC, Report to the Congress: Medicare Payment Policy, March 2019, Skilled nursing facility services, page 200. CMS recognizes that during the public health emergency active treatment may need to be modified. 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. According to the chart above, the total hourly cost for the DON is $94. In total, we estimate that information collection burden for all ICFs-IID would be about 170,274 hours and $11,425,674 in the first year and 86,580 hours and $5,350,644 in subsequent years. 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). The burden for each LTC facility would be 12 hours at an estimated cost of $804 (12 hours $67) for the IP. 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. Ensuring that all LTC facility residents, ICF-IID clients, and the staff who care for them are provided with ongoing opportunities to receive vaccination against COVID-19 is critical to ensuring that populations at higher risk of infection continue to be prioritized, and receive timely preventive care during the COVID-19 PHE. An ICF-IID administrator would likely work with the RN and need to approve the final educational material. Due to these high turnover rates, LTC facilities will require significantly more resident or staff vaccines compared to the total number of residents and staff in the facility at the beginning of the year. Ensuring that individuals residing in LTC facilities that did not participate in the Pharmacy Partnerships have access to vaccination against COVID-19 is critical so as to expeditiously ensure that residents are protected. DAVID A. LIEB and KAVISH HARJAI Associated Press, Do Not Sell or Share My Personal Information. Our expectation is that vaccination of regular visitors in any of these categories will be encouraged, whether or not the vaccinations are offered by the facility itself. We estimate that this would require 6 hours of an IP's time annually. 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. Box 8010, Baltimore, MD 21244-1850. Asymptomatic people with SARS-CoV-2 may move in and out of the LTC facility and the community, putting residents and staff at risk of infection. However, the Agency will not hesitate to use its full enforcement authority to protect the health and safety of patients. 12. Long-term care facilities, a category that includes Medicare SNFs and Medicaid nursing facilities (NFs), must meet the consolidated Medicare and Medicaid requirements for participation (requirements) for LTC facilities (42 CFR part 483, subpart B) that were first published in the Federal Register on February 2, 1989 (54 FR 5316). 89. 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. Get important prescribing information. Currently Medicaid pays for the administration of the COVID-19 vaccine to beneficiaries, and other public and private insurance providers are required to cover it as well. ICFs-IID have not historically been required to participate in national reporting programs to the extent that Start Printed Page 26309other health care facilities have. In order to standardize COVID-19 infection control and prevention in LTC facilities, we are issuing these requirements for facilities to provide COVID-19 vaccine education, offer COVID-19 vaccination, and report COVID-19 vaccinations for LTC facility residents and staff. 94. Bureau of Labor Statistics. 29. 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. edition of the Federal Register. We believe this educational material would likely be selected by the IP. According to Table 1 above, the total hourly cost for a financial clerk of $41. Title VII and the ADA, however, limit the ability of employers to do so. (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. In addition, we are requiring facilities to offer COVID-19 vaccines to residents, clients, and staff. The training is online, at http://QSEP.cms.gov,, and is summarized in a CMS press release that can be found at https://www.cms.gov/newsroom/press-releases/cms-releases-nursing-home-covid-19-training-data-urgent-call-action. The May 8th COVID-19 IFC established requirements for LTC facilities to report information related to COVID-19 cases among facility residents and staff. As estimated previously, the average annual cost of this rule is about $24.70 per resident or staff person in the first year. 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]. 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. 30. She focuses her practice inthe areas of regulatory and transactional health care, with experience representing physicians and healthcare providers and organizations with a broad spectrum of regulatory and transactional matters, including negotiating and documenting transactions, acquisitions, mergers and sales, joint ventures, integrated delivery systems and other combinations and alliances, employment agreements, recruitment and You are responsible for reading, understanding and agreeing to the National Law Review's (NLRs) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The Supreme Court today found that those challenging the CMS mandate were not likely to succeed on the merits because the Secretary has broad powers to impose conditions upon recipients of federal funds. Enforcement of the provisions of this IFC for LTC facilities will be similar to those requirements addressing influenza and pneumococcal vaccinations. 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). 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]. We estimate that this would require only a few seconds per resident, but estimate no costs as maintaining a medical record is a usual and customary business practice. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/specific-groups/allergies.html. Therefore, these activities for the DON associated with updating or changing the policies and procedures are exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). 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. over one-third are estimated to have died during or after a nursing home stay. documents in the last year, 887 In addition, we believe it would be overly burdensome for the ICF-IID to educate and offer the COVID-19 vaccine to all individuals who enter the facility. They may have wanted to impose one themselves, but feared workers would leave. Many states have either closed a significant number of these facilities completely or downsized them through rebalancing efforts,[7] A second major group within the same facilities receives short-term skilled nursing care services. Accessed on March 18, 2021. We are seeking public comment on the feasibility of adding appropriate COVID-19 vaccination requirements for residents, clients, and staff of all congregate living facilities where CMS has regulatory authority and pays for some portion of the care and services provided. As a practical matter, legislative or lawmaking power might be defined as writing rules that operate prospectively to constrain conduct. [77] See the previously cited CDC report on risks by age group. 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. The LTC Facility Toolkit: Preparing for COVID-19 Vaccination at Your Facility has information and resources to build confidence among staff and residents. offers a preview of documents scheduled to appear in the next day's 20. By continuing on our website, you agree to our use of the cookie for statistical and personalization purpose. COVID-19 vaccines are safe and effective. 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. 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. 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/. A program that discounts or increases premiums or cost sharing based on vaccination status is considered an activity-based wellness program and must be reasonably designed and offer the full reward to all similarly situated individuals. Assuming that the average rate of death from COVID-19 (following 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 value of each resident receiving the full course of two vaccines who would otherwise be infected with SARS-CoV-2 is about $530,000 ($10,600,000 .05). Title VII also requires employers to offer reasonable accommodations to employees who decline vaccination because of sincerely held religious beliefs, practices, or observations. 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. 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. The facilities remain responsible for the care and services provided to their residents. As we currently do not require LTC facilities to report vaccination status within their facility, we have no comprehensive way of knowing whether residents or staff of those facilities have acquired the vaccine through avenues outside the Partnerships. At 483.80(d)(3)(iv), we require that the LTC facility must provide to the staff, resident, or the resident representative, in situation where the vaccination process requires one or more doses of vaccine, up-to-date information regarding the vaccine, including any changes in the benefits or risks and potential side effects associated with the COVID-19 vaccine, before requesting consent for administration of each additional vaccinations. route, and needle length recommendations for all vaccines and recipients; Pricing for Each Schedule $10.00: 1 copy $9.50 each: 2-4 copies $8.50 each: 5-19 copies $7.50 . https://pediatrics.aappublications.org/content/145/3/e20193995. (3) COVID-19 immunizations. Laura Kelly, a Democrat who faced reelection in a Republican-leaning state, said last year that the vaccine mandate conflicted with state law and could worsen workforce shortages. Informal education may also occur as staff go about their daily duties, and some who have been vaccinated may promote vaccination to others. CDC has information describing IPC considerations for residents of ICF-IIDs with systemic signs and symptoms following COVID-19 vaccination. of this rule. 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. Bureau of Labor Statistics. By express or overnight mail. Staff should be provided education on culturally appropriate ways to educate and share information with clients to prevent misinformation, confusion, or loss of credibility. ICRs Regarding the ICFs-IID Offering the Vaccine and Obtaining and Documenting Consent in 483.460(a)(4)(i), 3. Ensuring that all residents, clients, and staff of LTC facilities and ICFs-IID have access to COVID-19 vaccinations seeks to address some of those inequities and provide timely protection for these individuals. Accessed at https://www.bls.gov/oes/current/oes119111.htm. Simply inquiring about vaccine status violates neither of these laws. (iii) Before offering COVID-19 vaccine, each client or the client's representative receives education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine. 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. 26. 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). It is critically important that facilities are required to continue to offer vaccination to their residents and staff on an ongoing basis. We note that for LTC facilities that participated in the Federal Pharmacy Partnership for Long-Term Care Program, pharmacies worked directly with LTC facilities to ensure staff who received the vaccine also received an EUA fact sheet before vaccination. Updated January 5, 2021. 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. As such, the vaccine mandate for eligible staff at Medicare and Medicaid-certified facilities is in effect. 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. https://tcf.org/content/commentary/even-nursing-homes-covid-19-racial-disparities-persist/?agreed=1. Reductions in resident, client, and staff mortality are benefits for which techniques exist (though with some uncertainty) to express estimates in dollar terms. documents in the last year, 1008 Enrollment in v-safe allows individuals to directly report to CDC any problems or adverse reactions after receiving the vaccine. USTR Releases 2023 Special 301 Report on Intellectual Property Washington Signs Into Law an Act for Consumer Health Data Privacy: Dont Look Twice, Its Alright The FCC Pulls Back the Curtain on Trending in Telehealth: April 18 24, 2023. Interim Guidance on Duration of Isolation and Precautions for Adults with COVID-19 | CDC , https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. 40. Vaccines may be administered onsite or at other appropriate locations. The combination of vaccination, universal source control (wearing masks), social distancing, and hand-washing offers further protection from COVID-19.[22]. We note that indications and contraindications for COVID-19 vaccination are evolving, and the director of nursing (DON) or nursing staff of the facility should be alert to any new or revised guidelines issued by CDC, FDA, vaccine manufacturers, and other expert stakeholders. These recommendations, which emphasize close monitoring of residents of long-term care facilities for symptoms of COVID-19, universal source control, physical distancing, hand hygiene, and optimizing engineering controls, are intended to help protect staff and residents from exposure. 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. Clients of ICFs-IID and their representatives must be offered education about vaccine immunization development, administration, and evaluation. 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. States and individual health systems have historically addressed vaccination requirements for diseases such as influenza and hepatitis B. One obvious example is whether vaccine efficacy will last more than the six months proven to date. We believe that the education provided to staff and residents or resident representatives will be identical or virtually the same. A growing number of states have enacted legislation directed at employer vaccine mandates. 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. Section 1871(b)(2)(C) of the Act and 5 U.S.C. Recent federal agency guidance makes these requirements clearer. https://www.cdc.gov/vaccines/covid-19/toolkits/long-term-care/. Staff education must cover the benefits of vaccination, which typically include reduced risk of COVID-19 illness and related serious COVID-19 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 continues. Vaccines are a crucial scientific tool in preserving and restoring efficient operations across the nations health care system while protecting individuals. Just 42% of adults in St. Clair County are vaccinated against COVID-19 a rate barely half the national average. including more than 131,000 LTC facility residents, or close to one tenth of the average national LTC facility resident census of 1.4 million. Occupational Employment and Wages, May 2019. Considering the cost savings from treating seriously ill residents, the financial impact is likely to be positive. It also does not prevent individuals from responding to such a question. The HIPAA privacy rule, which protects medical information, only applies to covered entities: health plans, health information clearinghouses, health care providers, and businesses that carry out health care functions and activities for them. It could backfire, I feared, in this political climate. Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff A Rule by the Centers for Medicare & Medicaid Services on 05/13/2021 Document Details Document Details Document Statistics National Law Review, Volume XII, Number 40, Public Services, Infrastructure, Transportation. Additionally, the pharmacy partners only collected numerator data (the number of residents and staff vaccinated), and not denominator data (the total number of residents and staff). We believe that the LTC facility will offer the vaccine to the staff or resident at the same time the facility provides the education required by 483.80(d)(3)(ii) and (iii). Today, the Supreme Court will hear oral argument in a pair of cases challenging President Joe Bidens vaccine mandates in two contexts: private workplaces with more than 100 employees and health-care facilities that participate in Medicare and Medicaid. Reporting is not required for the ICFs-IID, however we strongly encourage voluntary reporting. This would require that a health care provider, probably a licensed nurse, would retrieve the resident's medical record and document that the education was provided and whether the resident or resident representative had consented or refused the vaccine or whether the vaccine was contraindicated. documents in the last year, 204 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.
