Likewise, a COVID19 PHE declaration for the United States was made by the Secretary in January 2020, the President of the United States declared COVID19 a pandemic in March 2020, and the Secretary has sustained a PHE declaration since January 2020 with the final renewal occurring on February 9, 2023. Farida Ahmad et al, Provisional Mortality DataUnited States, 2021, at Organization and Purpose Additionally, some people may test negative on an antigen test but positive on a PCR test. 16. ) Section 485.70 is amended by removing paragraph (n). 1 CFR 1.1 The HHA must encode and transmit data using the software available from CMS or software that conforms to CMS standard electronic record layout, edit specifications, and data dictionary, and that includes the required OASIS data set. In Compliance with theConditions of Participation (CoP) is required to meet Medicare regulations. 68. These commenters emphasized that routine testing of staff for SARSCoV2 and use of PPE should be permitted in lieu of vaccination. [82] We acknowledge that most individuals are fortunate enough to recover from COVID19. [78] Just because they are daunting, it is still the Home Health Agency's responsibility to follow the Conditions of Participation. here. Hospital-Acquired Condition Reduction Program (HACRP). citations and headings For complete information about, and access to, our official publications Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates will impose spending costs on State, local, or Tribal governments, or by the private sector, require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In addition, as of March 30, 2023, 90.5 percent of counties, districts, or territories in the United States had a low community level of COVID19. on NARA's archives.gov. effectiveness in preventing COVID19, reducing disease severity, and risk of death, by those vaccinated are not currently known with precision or certainty. Testing for COVID19 helps to mitigate the transmission of the virus and thus improves patient outcomes and opportunities for socialization. (eg: Learn more about the eCFR, its status, and the editorial process. Costs Notes: The estimated effects of this rule on staff and patient lives saved or lost from COVID19 infections are not estimated. As discussed in the IFC, we recognize that assisting personnel are used by CORFs, and we established our requirements at 485.70(a) through (m) to provide a role for personnel that might not meet our education and experience qualifications. Following the rules will keep agencies compliant according to the rules which will reduce legal risk from both patients and CMS. Response: As mentioned above, based on an evaluation of the evolving clinical and epidemiological circumstances of the COVID19 pandemic, increased vaccine uptake, declining infection and death rates, decreasing severity of disease, increased instances of infection-induced immunity, public comments submitted to CMS, and the addition of COVID19 vaccination quality measures to quality improvement and reporting programs, we believe regulations regarding COVID19 vaccination of health care staff are no longer necessary. https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00059-X/fulltext. You can find that link here:CMS Interpretive Guidelines. Regulations & Guidance Conditions for Coverage (CfCs) & Conditions of Participations (CoPs) Home Health Agencies Home Health Agencies Existing CoPs- Aug. 14, 1989 (54 FR 33367) Amendments on: July 18, 1991 (56 FR 32973) Oct. 11, 1991 (56 FR 51334) Feb. 28, 1992 (57 FR 7136) Mar. The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. These markup elements allow the user to see how the document follows the Some commenters suggested additional educational outreach, especially among communities with lower trust in the health care system, as well as an understanding of the logistical issues preventing prompt implementation of the requirements in the staff vaccination IFC at certain facilities. Critical Access Hospitals (CAHs)485.640(f). [12] It is not an official legal edition of the Federal Secure .gov websites use HTTPSA In response to this IFC we received approximately 169 comments, of which about 150 addressed the COVID19 testing requirements for LTC facilities' staff and residents. Response: Comment: [6] This final rule 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. 73. (1) Any discharge planning evaluation must be made on a timely basis to ensure that appropriate arrangements for post-hospital care will be made before discharge and to avoid unnecessary delays in discharge. 27. CMS develops Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. Certain individuals, depending on age and level of immunocompromise, may receive additional doses. (2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. Information about this document as published in the Federal Register. DISCLAIMER: The contents of this database lack the force and effect of law, except as (i) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech language pathology services, (A) The registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient's needs; and. What is still uncertain is how staff or patient compliance with recommended vaccinations may change further over time. 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). While these trends reflect a confluence of factors, including unprecedented stress, trauma, overwhelming loss associated with death of coworkers and patients (particularly for nurses who typically witness decline and death), and self-isolation or quarantine from families, we also understand commenters' concern that the requirements in the staff vaccination IFC would further add to those shortages. This web site is designed for the current versions of Delve into the survey process, learn how to prepare including how to conduct mock surveys and implement compliant processes, so you can ultimately avoid hefty CMS penalties at your next survey. Response: These commenters expressed concern that the staff vaccination requirements would cause a mass flight of unvaccinated health care workers from the industry. Friday, June 25, 2021. 92. Additionally, the CDC provides guidance on proper specimen collection at Completion of HCP status varied in case reporting over time and is noted in the figure and table below. JavaScript seems to be disabled in your browser. 83. Choosing an item from While a comprehensive discussion of CMS' regulatory responses during the PHE is outside the scope and purpose of this final rule, we note that CMS issued several interim final rules with comment periods (IFCs) during the COVID19 PHE to help minimize the This feature is not available for this document. However, we did not believe this exception for employees who did not meet our professional requirements should have prohibited us from issuing staff qualifications referencing infection prevention, which we intended to apply to all personnel. Accessed on January 17, 2023. Because these COPs and Standards have been put out by CMS, it is not Home Care Answers place to offer guidance or interpretation of these standards and COPs. Issued by: Centers for Medicare & Medicaid Services (CMS). Classroom and supervised practical training must total at least 75 hours. Accessed on January 17, 2023. The IFC required facilities to track and securely document the vaccination status of each staff member. 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). Specifically, LTC facilities must report all required data until December 31, 2024, as determined by the Secretary. Given the many uncertainties as to future events, and with the option of new emergency regulations available under appropriate circumstances if progress is halted or reversed, a rule tailored to future events could always be created should the data justify such an action. This opportunity is particularly large for booster shots, since only about 22 percent of nursing home staff, and presumably a similar percentage for other provider types, have even obtained the first booster. Comment: Furthermore, CMS uses existing lines of communication with stakeholders in an effort to address some of these questions and concerns. 78. 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. The proportion of the unvaccinated who have contracted the virus has also contributed to reducing the rate of future infections and their severity. We suggest that agencies take a section out of the COPs and discuss it at every staff meeting. Sections 1861(aa) and 1905(l)(2)(B) of the Act. We then discuss the final regulatory changes pertaining to the educate and offer provisions in section IV.B. Background and more details are available in the Some of these commenters shared that there was confusion in the messaging coming from CMS regarding boosters and potential discrepancies between the IFC and contemporary information aids coming from other parts of the executive branch. Some medications mentioned by commenters, such as Ivermectin and vitamin D, are not evidence-based treatments for COVID19. [26] [34] Public commenters also addressed the reporting requirements, which we addressed in the CY 2022 Home Health Prospective Payment System final rule (86 FR 62240, 62392). As noted in the preamble of the IFC, we made efforts to mitigate the burden on providers by not requiring that each provider and supplier ensure COVID19 vaccination for all individuals who entered the facility or setting of care, because we believed such a requirement would be overly burdensome. 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. 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. For LTC facilities, the educate and offer IFC established 42 CFR 483.80(d)(3) COVID19 immunizations, under which facilities must develop and implement policies and procedures to ensure that all of the requirements set forth in that section are followed. Section 1102(b) of the Act requires us to prepare an RIA if a proposed or final rule may have a significant impact on the operations of a substantial number of small rural hospitals. (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. We recommend you directly contact the agency associated with the content in question. Vaccination is required for all staff that interact with other staff or patients in any location, such as clinics, homes, or other sites of care and services. Response: (f) Standard: Eligible training and competency evaluation organizations. Therefore, it is important that we maintain the educate and offer provisions for both LTC facilities and ICFIIDs. result, it may not include the most recent changes applied to the CFR. Several commenters expressed burden concerns due to high staff turnover rates, which have increased the amount of time needed to provide education and to offer the vaccine to staff. The person who tests positive upon admission to a hospital most likely reached the hospital after contracting the disease in another setting. [20] As previously discussed, LTC facility residents are more susceptible to contracting COVID19 and developing severe symptoms. These comments also discussed how it is challenging to comply with the requirements due to limited availability of PPE. 1395aaa1(a)) and section 1890(b)(7)(B) of the Act (42 U.S.C. 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. (B) The home health aide does not need to be present during this visit. As discussed in the staff vaccination IFC, we understand that some States and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC. 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. In this final rule, we are finalizing the education and offering provisions of the educate and offer IFC, as amended by the staff vaccination IFC, and we refer readers to sections I., II.B., III.B., IV.B., V.B, and VI.B. Accordingly, we issued the staff vaccination IFC, which required most Medicare- and Medicaid-certified providers and suppliers to ensure health care staff completed their COVID19 primary vaccine series. Search & Navigation 28. As of May 2, 2023, the CDC recommends that individuals 6 months of age and older receive a dose of updated (bivalent) vaccine. Regulation Y (3) If a deficiency in aide services is verified by the registered nurse or other appropriate skilled professional during an on-site visit, then the agency must conduct, and the home health aide must complete, retraining and a competency evaluation for the deficient and all related skills. All individuals aged >6 months are recommended to receive at least one dose of bivalent vaccine for COVID19 under current recommendations. full text search results We required at 483.80(h)(6) that the LTC facility coordinate with state and local health departments and Tribal representatives regarding the availability and obtaining of testing supplies and processing test results when necessary. 79. Since the IFC was issued, CDC shifted to using the terminology up to date. 20. The discharge plan must be updated, as needed, to reflect these changes. The authority citation for part 485 continues to read as follows: Authority: https://www.cdc.gov/nchs/covid19/faq.htm. 12. These comments discussed how it is challenging to comply with this requirement due to the increased turnaround time to receive results and the limited number of staff members. Classroom and supervised practical training must be performed by a registered nurse who possesses a minimum of 2 years nursing experience, at least 1 year of which must be in home health care, or by other individuals under the general supervision of the registered nurse. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/past-reports/033123.html#:~:text=COVID%2D19%20Community%20Levels*,with%20a%20low%20Community%20Level. Readers may find more information regarding pooled testing at These projections showed lower estimates for future years than upfront, in large part because the need for development of policies, procedures, and educational materials would be greatly reduced over time. While many commenters supported the COVID19 vaccination requirements, the majority of commenters stated that CMS did not have the statutory authority to infringe on the personal rights of health care staff to choose vaccination or not. https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf. Did you know that there are 20 Conditions of Participation for Home Health Agencies? Start Printed Page 36499 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. 76. The central consideration in our evaluation and determination is helping to protect the health and safety of individuals that receive care and services from Medicare- and Medicaid-certified providers and suppliers. In order to get a CMS Certification Number, the agency agrees to abide by the rules. The Interpretive Guidelines will be incorporated into the State Operations Manual (SOM), Appendix B. By doing so, LTC facilities must continue to educate residents, resident representatives, and staff about COVID19 vaccines and offer a COVID19 vaccine to residents, resident representatives, and staff, as well as complete the appropriate documentation for these activities. According to the Centers for Disease Control and Prevention (CDC), just over 6 million patients admitted to hospitals in the United States have been confirmed positive with COVID19 infection since August 1, 2020, and approximately 1.1 million COVID19 deaths have been reported in the United States as of April 14, 2023. [79] Section 482.42 is amended by removing paragraph (g). within the 3-year time limit imposed by section 902 of the MMA. Here we touch on the top headlines with a version for those in a hurry and those who wish to know more! At 483.80(h)(2), we required that all residents and staff testing be conducted in a manner consistent with current professional standards of practice for conducting COVID19 tests. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel_healthcare-deaths. Response: Comment: 263a and 1302. [FR Doc. We have written about QAPI in a previous blog, which is a COP. These commenters are incorrect in their assumption of a violation of E.O. A separate drafting site Also, here a link to the Federal Register with the Conditions of Participation. Currently available data do not show that Ivermectin is effective against COVID19 and taking large doses of Ivermectin is dangerous. 46. The Department may not cite, use, or rely on any guidance that is not posted Vaccination still remains as one of the most important methods to help reduce severity of COVID19. Thus, existing educate and offer requirements focus on both nursing home staff and patients. This is true, of course, for workers as well. [90] Learn more. Exceptions based on infection-induced immunity are also challenging to apply and enforce fairly, as verification of a health care worker's prior infection or antibody levels may not be possible in all cases. Many commenters stated a belief that vaccines are ineffective. Response: We thank commenters for recognizing the gravity of the COVID19 pandemic and their appreciation for resident and client health and safety. Further, the CDC has published guidance on how to optimize PPE at Section 416.51 is amended by removing paragraph (c). The .gov means its official. 82 FR 4578, Jan. 13, 2017, unless otherwise noted. A significant minority of commenters agreed with our goal to ensure patient health and safety by establishing a COVID19 health care staff vaccination requirement. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines. We subsequently finalized data reporting requirements for LTC facilities with revisions in the final rule Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID19 Reporting Requirements for Long-Term Care Facilities, published in the November 9, 2021 Ignorance is no defense if something goes wrong in home health. Table 4Accounting StatementClassification of Estimated Costs and Savings Relative to an Analytic Baseline in Which the Staff Vaccination and Educate-and-Offer IFCs Are Retained Into the Future. The use of such quality measures may ultimately affect ratings on the various Compare (such as Hospital Compare) websites and may affect payment in various value-based purchasing programs, but would not affect the ability of the provider or supplier to participate in the Medicare program. We acknowledge that previous COVID19 infection may also contribute to protection against subsequent infection and associated severe, critical, or fatal COVID19. We thank commenters for sharing their understanding of the importance of testing for COVID19. (b) Standard: Discharge of the patient and provision and transmission of the patient's necessary medical information. 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. The majority of comments stressed how these new testing requirements are diverting resources and adding an additional burden to the staff, who are already strained by the staffing shortage. See Table 6 in that rule, at 86 FR 26330, May 13, 2021. Further, many Americans have been infected with COVID19 and may have developed some level of infection-induced immunity, which provides some protections as well. 41. ( i) This list must only be presented to patients for whom home health care post-hospital extended care services, SNF, IRF, or LTCH services are indicated and appropriate as determined by the discharge planning evaluation. [22] were virtually identical letters from individuals from around the country urging CMS to retract the rule. For purposes of the RFA, we estimate that most health care facilities are small entities as that term is used in the RFA because they are either nonprofit organizations or meet the SBA definition of a small business (for most types of health care providers, having revenues of less than $8.0 million to $41.5 million in any 1 year). A few comments appealed for permission to utilize pool testing methods for the routine testing of all staff and to focus routine staff testing on those who have the greatest risk of exposure and transmission, such as those who have direct contact with patients. We estimated with these omissions because we had no reliable way to estimate how much of these costs might be due to independent employer decisions, to other Federal standards, to State and local mandates, or to individual personal choices. Additional information regarding vaccine guidance can be found at https://www.federalregister.gov/documents/2021/11/09/2021-23993/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home. We did not prohibit such extensions and encouraged facilities to require COVID19 vaccination for these individuals as reasonably feasible.