Several of these commenters explained that a high community rate may be skewed by isolated populations, such as incarcerated individuals or college and university students. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Certain individuals, depending on age and level of immunocompromise, may receive additional doses. of this final rule, we address the public comments submitted to CMS regarding the staff vaccination IFC. However, some individuals may face additional barriers accessing COVID19 vaccines. 12866 as amended by E.O. A better understanding of the value of vaccination may allow staff to appropriately educate residents and their family members about the benefits of accepting the vaccine. https://aspr.hhs.gov/legal/PHE/Pages/default.aspx. However, payment for these treatments is outside the scope of this rule. Enhanced content is provided to the user to provide additional context. These markup elements allow the user to see how the document follows the "Published Edition". Long-Term Care Hospital Quality Reporting Program (LTCHQRP). 72. We appreciate the feedback from commenters. 1302 and 1395hh. Its provisions made no distinctions as to ownership status of any facility, whether owned or administered by a private organization, State or local government, or tribe. We acknowledged in the IFC that certain allergies or medical conditions may be clinical contraindications to receiving a COVID19 vaccine, and we referred facilities to the CDC page Use of COVID19 Vaccines in the United States: Interim Clinical Considerations which can be accessed at Learn more about the eCFR, its status, and the editorial process. Nonetheless, evidence continued to demonstrate that unvaccinated health care staff presented risks to patient safety across health care settings, and that too few health care staff were getting vaccinated. 26. . Rural Health Clinics (RHCs) and Medicare Federally Qualified Health Centers (FQHCs)491.8(d). lock general public. Commenters stated that COVID19 vaccination is evidence-based, safe, and the best way to prevent serious illness, hospitalization, death, and spread of infection. In this section, CMS discusses the public comments received for the COVID19 testing requirement for LTC facilities, the staff vaccination IFC, and the educate and offer provisions of the COVID19 Vaccine Requirements for LTC Facilities and ICFsIID Residents, Clients, and Staff IFC (educate and offer IFC), published September 2, 2020, November 5, 2021, and May 21, 2021, respectively. DA welcomes the extension of public participation process for Draft Instead, it reduces regulatory costs to health care providers and suppliers by withdrawing the requirements imposed by the staff vaccination IFC issued in November 2021. 3. https://www.benefits.gov/benefit/641. Further, the CDC has published guidance on how to optimize PPE at In order to participate in and receive federal payment from Medicare or Medicaid programs, a health care organization must meet the government requirements for program participation, including a certification of compliance with the health and safety requirements called Conditions of Participation (CoPs) or Conditions for Coverage (CfCs), which are set forth in federal regulations. [31] Table 3 lists the regulatory locations from which staff vaccination regulations are addressed in this final rule by provider and supplier type. Since ICFIID staff may be required to take a COVID19 vaccine in some States, or by some employers, we believe it is inappropriate to include explicit permission to refuse in the regulations. We thank commenters for recognizing the importance of collecting accurate data and its use for informing an appropriate pandemic response. revenues to a provider of more than 3 to 5 percent as its measure of significant economic impact. The HHS standard for substantial number is 5 percent or more of those that will be significantly impacted, but never fewer than 20. Sections 1819(d)(4)(B), 1819(f)(1), and 1919(d)(4)(B) and (f)(1) of the Act. These uncertainties also impinge on benefits estimates. developer resources. In this final rule, we are withdrawing the health care staff COVID19 vaccination provisions issued in the staff vaccination IFC and deleting the expired COVID19 testing provisions of the LTC testing IFC. Reinfection of previously vaccinated persons or of previously infected persons would make them a temporary risk, but the frequency of this problem appears to be quite low. Comment: Further, frequent testing for COVID19 remains an important tool for mitigating the transmission of the virus. [9192] This final rule was not preceded by a notice of proposed rulemaking, and therefore the requirements of UMRA do not apply. Within the IFC, we briefly discussed the OSHA IFC, Occupational Exposure to COVID19; Emergency Temporary Standard (86 FR 32376, June 21, 2021), that was applicable to health care settings at the time of publication, including but not limited to the providers and suppliers who must comply with the staff vaccination IFC, because the OSHA ETS and the IFC had complementary requirements. Additionally, some people may test negative on an antigen test but positive on a PCR test. 2:22CV149 DAKDBP (D. Utah Oct. 13, 2022). These drugs have also undergone rigorous testing. In the LTC facility testing IFC, we revised the LTC facility infection control requirements applicable for the duration of the PHE at 483.80 to establish a new, term-limited requirement that LTC facilities to test their facility residents and staff for COVID19, including individuals providing services under arrangement and volunteers. These commenters are incorrect in their assumption of a violation of E.O. As we discussed in the staff vaccination IFC, we believe it would be overly burdensome to require that facilities ensure COVID19 vaccination for all individuals who enter (patients, visitors, mail carriers, etc.). 273, 1302, 1320b8, and 1395hh. About the Federal Register (a)Standard: Prevention. In comparison, roughly 200 healthcare worker deaths occurred from COVID19, much and perhaps most contracted outside the workplace. The following sections of the Act are also pertinent: eCFR :: 42 CFR 484.80 -- Condition of participation: Home health aide Since facilities are no longer operating under PHE circumstances, and considering the lower policy priority of enforcement within the remaining time, we will not be enforcing the staff vaccination provisions between now and August 4, 2023. The following providers and suppliers were regulated by the staff vaccination IFC, listed in the numerical order of the relevant Code of Federal Regulations (CFR) sections: We discuss the specific requirements of the staff vaccination IFC in section II.A. We believe that the educate and offer requirements comply with these statutory requirements. There are also 69 Standards set forth under the COPs that agencies need to follow. Specifically, staffing shortages peaked nationally during the Omicron wave, with nearly one in three facilities reporting a shortage in January 2022. The COPs are there to protect agencies and patients. These facilities are the most important locations for patient education, both to protect other patients and to protect staff. For technical inquiries: Hence, we are finalizing the refusal provision as amended by the staff vaccination IFC. Several of the policies in these IFCs have been further addressed in final rules and through the COVID19 vaccination quality measures which have been proposed for adoption in multiple CMS quality reporting and payment programs (for example, the Measures Under Consideration (MUC) List issued by CMS on December 1, 2022). When a COVID19 vaccine is available to the facility, each resident and staff member is offered a COVID19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized. Likewise, there is little or no reason to expect that the expiration of the LTC facility testing IFC will have a consequential effect. Due to . Likewise, some commenters noted that the CDC did not include boosters in its definition of fully vaccinated at the time that the rule was issued. Most States have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that were not subject to the vaccination requirements in the IFC. [24]. End-Stage Renal Disease (ESRD) Facilities494.30(b). https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html#recommendations). Choosing an item from Comment: This informative series will cover agency and clinical requirements, QAPI, the survey process and prep, and so much more. The facility must also document that staff were either offered the COVID19 vaccine or provided with information on acquiring the COVID19 vaccine. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2794727?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=072922. (3) The discharge planning evaluation must be included in the patient's medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient's representative). The President of the United States declared the COVID19 pandemic a national emergency on March 13, 2020. The initial determination that a PHE for COVID19 exists and had existed since January 27, 2020, lasted for 90 days, and was renewed by the Secretary on April 21, 2020; July 23, 2020; October 2, 2020; January 7, 2021; April 15, 2021; July 19, 2021; October 15, 2021; January 14, 2022; April 12, 2022; July 15, 2022; October 13, 2022; January 11, 2023; and February 9, 2023. 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). The following analysis covers the ICRs for the Staff Vaccination, Educate and Offer, and LTC testing requirements. 3:21cv3970 (W.D. https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard. of this final rule, we discuss the comments and responses pertaining to the COVID19 health care staff vaccination requirements. Comment: [20] Response: 18. 485.916. We then discuss any additional revisions for specific provider and supplier types issued by CMS in the staff vaccination IFC due to unique circumstances. Start Printed Page 36499 Section 1861 (dd) of the Act specifies services covered as hospice care and the conditions that a hospice program must meet in order to participate in the Medicare program. Omnibus COVID19 Health Care Staff Vaccination, 1. 21. Inpatient Rehabilitation Facility Quality Reporting Program (IRFQRP). The analysis in this RIA and the preamble as a whole would, however, meet the requirements of UMRA. In response to this IFC, we received approximately 10,102 timely public comments. The IFC also established additional infection control requirements for LTC facilities, as well as requirements to report certain COVID19 data: these requirements have already been finalized through previous rulemaking (86 FR 62240). 85. (f) Standard: Eligible training and competency evaluation organizations. 30. 16. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html. This final rule's effect on numbers of lives lost of either health care staff or health care patients is limited by the scope of such outcomes in the analytic baseline (that is, the future trajectory in this rule's absence). Of particular importance, the interactive effect of both staff and patient COVID19 vaccination rates reaching or approaching 90 percent has helped each group protect the other. 65. A longer period would be even more speculative than the current estimates. Moreover, efforts to speed the vaccine development process have not sacrificed scientific standards, integrity of the vaccine review process, or safety. Second, the location where a patient is treated or dies may have little or no relevance to where they became infected. Response: https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Flong-term-care.html. If Nursing is part of the initial referral with PT and Speech, can a PT do the initial assessment or must an RN do it? (iii) If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care. This IFC applied only to certain health care providers and suppliers who voluntarily enrolled in the Medicare and Medicaid programs. Home Health Survey Trainer, 2023 Available December 2022 Ensure your home health agency's policies and procedures are up to par as surveyors hone in. incorporated into a contract. Since that ruling, two plaintiff States voluntarily dismissed challenges to the rule, and Federal courts have dismissed two other cases. Comment: The transition CMS is making now, to make COVID19 policies more like those for other communicable diseases, reflects the ongoing evolution of epidemiological and clinical circumstances; it does not imply that our issuance of the staff vaccination IFC was invalid or that CMS could not take such steps again in the future, if circumstances warrant. Likewise, at the time the IFC was published, ICFsIID had existing regulations at 483.460(a)(4)(v) that required facilities to educate all clients and staff about the COVID19 vaccines and to offer the vaccine, when available. In this final rule, we are finalizing the infection control requirements that LTC facilities must meet to participate in the Medicare and Medicaid programs as issued in the educate and offer IFC and amended by the staff vaccination IFC. (vi) Maintenance of a clean, safe, and healthy environment. Final Decision: The accuracy of our estimate of the information collection burden. 7500 Security Boulevard, Baltimore, MD 21244, An official website of the United States government, Conditions for Coverage (CfCs) & Conditions of Participations (CoPs), Rural Health Clinic/Federally Qualified Health Center, Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID), Religious Nonmedical Health Care Institutions, Comprehensive Outpatient Rehabilitation Facilities (CORFs), Clinics, Rehab Agencies, & Public Health Agencies as Providers of Outpatient PT and Speech Language, CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES, Jan. 25, 1999 (64 FR 3763 and 64 FR 3784). Hospital Inpatient Quality Reporting Program (Hospital IQR Program). Comment: 13175. When applying for accreditation, select the box for age-friendly care. Heres how you know. The Accounting Table (Table 4) summarizes the quantified impact of this rule. This is the rounded weighted average annual cost of healthcare employees as estimated in the Totals line of Table 4 of the mandated vaccination interim final rule issued in November of 2021, op cit. These commenters expressed that this blanket approach may not be appropriate for all LTC facilities and suggested that the testing of staff should be reduced in order to appropriately allocate limited and costly testing supplies and resources. But large as these numbers are, they are dwarfed by the number of patients served. [46] Although we are withdrawing the health care staff COVID19 vaccination provisions of the IFC for the reasons discussed throughout this preamble, we disagree with the comments regarding CMS' statutory authority to issue the rule. 38. By doing so, ICFsIID must continue to educate clients, client representatives, and staff and offer the COVID19 vaccine to clients and staff, as well as perform the appropriate documentation for these activities. CMS has also given guidance and interpretation of the COPs and Standards. The preceding discussion applies to the staff vaccination IFC. CMS continues to engage with external stakeholders and strives towards providing, supporting, and fostering culturally-competent and person-centered care for these populations. We continue to explore different approaches to support and incentivize the use of effective combinations of preventive layers in particular circumstances and the best, most flexible way to support their application. Other groups, particularly in long-term care, asked whether contractors (a one-off or incidental plumber, or a fully remote administrative staff worker, for example) would be required to be vaccinated in order for the facility to be considered in compliance. See Table 6 in that rule, at 86 FR 26330, May 13, 2021. Compliance Cost Reduction. It is important for data to be measured and reported in a standardized manner. authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically full text search results COPs, OASIS, and compliance aren't going anywhere. In addition, parallel Medicaid statutes provide authority to establish requirements to protect the health and safety of patients. Classroom and supervised practical training must total at least 75 hours. We also discussed special precautions to be taken in the event of, for example, a regional or local emergency declaration, such as for a hurricane or flooding, which necessitated the temporary utilization of unvaccinated staff, in order to assure the health and safety of patients. At this point in time, we believe that the risks targeted by the staff vaccination IFC have been largely addressed, so we are now aligning our approach with those for other infectious diseases, specifically influenza. What are the Conditions of Participation for Home Health? https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19. As previously discussed, many of the residents and clients of LTC facilities and ICFIIDs are not able to independently travel offsite in order to receive a vaccine due to several factors including but not limited to disability, cognitive impairment, low health literacy, and/or functional reasons. As reflected by the fact that they these three categories of requirements appeared in three separate IFCs, the provisions of this final rule that relate to each of these three categories operate independently, and the agency intends that they be treated as severable. As many Home Health patients are often vulnerable, it is especially important to note that the patients rights are essential to protecting human dignity and patient safety. Navigate by entering citations or phrases These commenters described the requirements as an overreach of CMS authority and a violation of personal freedoms and bodily autonomy. See 86 FR 61603 and 61606, November 5, 2021. [14] https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00059-X/fulltext. Hence, we are finalizing the provision as amended by the staff vaccination IFC, which provides, at 483.80(d)(3)(vii) that the facility maintains documentation related to staff COVID19 vaccination. I have read through them many times preparing for this blog. As discussed in the next section of this RIA, we believe it very likely that many and probably most health care providers and suppliers will continue to require or strongly urge staff vaccination and that staff vaccination rates will rise over time as new generations of workers who received past vaccinations will be hired. https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/1918-pandemic-history.htm. will bring you to those results. As discussed in the staff vaccination IFC, PRTFs, HIT Suppliers, and RHCs/FQHCs did not have specific infection control and prevention regulations at the time the IFC was published. However, as previously noted, we are withdrawing the health care staff COVID19 vaccination provisions. The requirements for COVID19 testing of LTC facility staff have already expired. In retrospect, it appears that while our cost estimates may have been reasonably robust, any estimate of lives saved would have Pressing enter in the search box In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. If you have questions for the Agency that issued the current document please contact the agency directly. JavaScript seems to be disabled in your browser. Information about this document as published in the Federal Register. Furthermore, the commenters identified no specific government-to-government effects from the rulemaking that would adversely affect tribes. "Published Edition". [82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021]. As we stated above in section II.B.1. [5859] We acknowledge that most individuals are fortunate enough to recover from COVID19. Boosters have been an important part of protecting people from getting seriously ill or dying from COVID19. A hospice provider must have regulatory competency in navigating these requirements. Accordingly, we have prepared an RIA that, taken together with the collection of information (COI) analysis and other sections of this preamble, presents to the best of our ability the costs and benefits of the rulemaking.
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