Nearly two years after issuing the temporary final rule requiring COVID-19 vaccination for certain health care businesses, the Centers for Medicare and Medicaid Services (“CMS”) has issued a final rule addressing several regulations related to COVID-19 vaccination, testing and education requirements in facilities. health care.
In short, the rule eliminates the COVID-19 vaccine requirement for employees in certain categories of Medicare participating health care providers and ends the COVID-19 vaccination testing requirement for employees in long-term care (“LTC”) facilities. In addition, the rule finalizes previous temporary provisions related to COVID-19 “education and display” vaccination requirements for residents, staff, and clients of LTC facilities and intermediate care facilities for individuals with intellectual disabilities (“ICFs-IID”).
The rule states that a rollback of COVID-19 vaccination and testing requirements enacted during the pandemic corresponds to the end of the Public Health Emergency (“PHE”) on May 11, 2023 and the concomitant decline in infection rates, decreased mortality, and significant vaccination uptake of before the public.
Although rules generally take 60 days after the date of publication in the Federal Register to become effective, CMS says it will exercise discretion to comply with the canceled vaccination rules between now and the expected date — August 4, 2023 — in other words, compliance with these requirements is no longer necessary as of The publication date of the rule is June 5, 2023.
A new rule changes three rules for the epidemic era
The rule has a combined effect on three pandemic-era rules that were put in place to help stop the spread of COVID-19 through vulnerable populations in healthcare facilities:
- The first rule was issued in September 2020 as a temporary final rule with a hold period related to requirements for COVID-19 testing at LTC facilities (the “LTC Testing Rule”). This rule, among other things, mandated that LTC facilities routinely test residents and staff for COVID-19. be seen 42 CFR § 483.80(h).
- Rule II issued in May 2021 revised Requirements for LTC Facilities and Conditions of Participation (“CoPs”) for ICFs-IIDs, requiring that these types of facilities provide COVID-19 vaccine education and offer immunizations to employees, customers, and residents (“Educate and Offer Rule”); CMS has also revised infection control requirements for LTC facilities to include reporting of COVID-19 data as part of this rulemaking.
- Rule Three was posted in November 2021 as a temporary final rule and imposed employee COVID-19 vaccination requirements and conditions for coverage (“CfCs”) on selected Medicare and Medicaid providers and suppliers, which included requirements to track and document employee vaccination status and create a process by which employees can request a waiver of Vaccination (“Staff Vaccination Rule”).
The status of each of these rules and changes to them are summarized below.
LTC testing and vaccination rules for medical care provider and suppliers
The newly issued rule overrules LTC testing requirements by deleting the COVID-19 testing provisions that were codified under 42 CFR § 483.80(h) by the temporary LTC testing rule. CMS clarifies that these testing requirements were not and are not in effect after PHE ended on May 11, 2023. Likewise, the new rule withdraws regulatory provisions that mandate COVID-19 vaccination policies and procedures for health care personnel under the Employee Vaccination Rule.
Accordingly, covered Medicare and Medicaid providers and vendors are no longer required to comply with employee vaccination, track and document COPs and CfCs, and requirements created by the Employee Vaccination Rule, and LTC facilities are no longer subject to mandatory employee testing standards. However, as described below, vaccination education and presentation criteria still apply to LTC and ICFs-IID facilities.
The new rule stresses that ending COVID-19 vaccination requirements for CMS employees and LTC facility testing does not preclude health facilities from imposing similar requirements on their own, and CMS encourages health care employers to maintain “evidence-based policies” regarding employee vaccination for COVID. – 19 and other infectious diseases. To that end, CMS said it plans to subsidize its COVID-19 vaccines through quality standards and other regulatory mechanisms, which are currently being developed.
For example, CMS is considering adopting, through future rulemaking, certain Medicare Quality Program standards with respect to COVID-19 vaccination procedures and reported performance information under Medicare, including the merit-based stimulus payment system (MIPS). Accordingly, regulated entities should monitor any development of rules or guidance from CMS addressing new COVID-19 vaccine quality measures and other quality-based vaccination initiatives.
It should be noted that the employee vaccination and revocation rule does not directly apply to or affect employers or other entities, including other healthcare entities, such as physicians’ offices, that are not regulated by CMS. Furthermore, stagnating LTC testing and employee vaccination rules does not alter compliance with applicable state or local laws mandating COVID-19 vaccination and related requirements on regulated health care facilities, providers and/or suppliers.
Education on vaccinations against COVID-19 and provision of the rule
As noted above, CMS issued a rule in May 2021 that requires LTC facilities and ICFs-IIDs to provide COVID-19 vaccination education and to offer vaccines to residents, employees, and customers. According to the newly issued rule, temporary education and display requirements — codified under 42 CFR Sections 483.80(d), 483.430(f), and 483.460(a)(4)—are now being completed on a permanent basis.
As such, LTC facilities must comply with requirements for infection control, i.e. vaccination education and provision of operations under 42 CFR § 483.80(d), to participate in Medicare and Medicaid programs; The ICFs-IID must comply with the COVID-19 vaccination of facility employees, vaccination education, and provision of operations (pursuant to 42 CFR §§ 483.430(f) and 483.460(a)(4)) to participate in Medicare and Medicaid programs moving forward.
Thus, LTC facilities and ICFs-IIDs will need to continue to monitor and maintain ongoing compliance with this vaccine education and supply requirements, even after the end of PHE. Further, CMS does not permit employees to refuse vaccination against COVID-19 under the Education and Display provisions, stating that such permission could contravene state laws requiring vaccination and conflict with the overall goals of protecting the health and safety of residents, customers and employees under the rule.
In response to the comments, CMS stresses the importance of education and submission of requirements as necessary “to ensure that the population most vulnerable to infection continues to be prioritized and receive timely preventative care during the COVID-19 pandemic.” CMS also notes concern about non-compliance with provisional education and display requirements as another reason behind its decision to finalize such regulations. Education and presentation requirements apply to all LTC facilities and ICFs-IIDs (regardless of whether a “W-2” relationship is involved), which includes anyone who works in a facility at least once a week. The new rule also explains that these requirements extend to “individuals who may not be physically in an LTC facility for a period of time due to illness, disability, or scheduled leave, but who are expected to return to work.” As such, LTC facilities and ICFs-IIDs must ensure that employees with anticipated changes in working arrangements — for example, employees who will stop working remotely — receive vaccination education and provide services in accordance with this rule, as appropriate.
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