Nearly two years after issuing its final interim rule requiring COVID-19 vaccination for certain health care workers, the Centers for Medicare and Medicaid Services (“CMS”) has issued a final rule addressing several regulations regarding vaccination, i COVID-19 testing and education requirements in healthcare settings.
In summary, the rule eliminates the COVID-19 vaccination requirement for staff of certain categories of health care providers participating in Medicare and ends the COVID-19 vaccination testing requirement for staff in long-term care facilities (“LTC”). In addition, the rule finalizes previously interim provisions regarding COVID-19 immunization “education and provision” requirements for residents, staff, and clients at LTC and Intermediate Care Facilities for Persons with Intellectual Disabilities (“ICFs-IIDs”). ).
The rule states that the reinstatement of COVID-19 vaccination and testing requirements enacted during the pandemic is in line with the end of the Public Health Emergency (“PHE”) on May 11, 2023 and the concomitant reduction in infection rates, decline of deaths and significant vaccination uptake by the public.
Although the rules generally take 60 days after the date of publication in the Federal Register to take effect, CMS says it will exercise enforcement discretion for compliance with the revoked vaccination rules between now and that scheduled date, August 4, 2023, in in other words, compliance with these requirements are no longer necessary from the date of publication of the standard on June 5, 2023.
The new rule changes three pandemic-era rules
The rule has a combined effect on three pandemic-era rules that have been put in place to help stem the spread of COVID-19 through vulnerable populations in healthcare settings:
- The first rule issued in September 2020 as an interim final rule with comment period covered COVID-19 testing requirements at LTC facilities (“LTC Testing Rule”). This rule, among other things, required LTC facilities to routinely test residents and staff for COVID-19. See 42 CFR § 483.80(h).
- The second rule issued in May 2021 revised the requirements for LTC facilities and conditions of participation (“CoP”) for ICF-IID, requiring these types of facilities to provide COVID-19 vaccine training and offer vaccinations to staff, customers and residents (“Educate and Offer Rule”); CMS has also revised the infection control requirements for LTC facilities to include reporting of COVID-19 data as part of this regulation.
- The third rule was published in November 2021 as an interim final rule and imposed COVID-19 Staff Immunization and Terms of Coverage (“CfC”) requirements on specific Medicare and Medicaid providers and providers, which included requirements to track and document staff vaccination status and establish a process by which staff can apply for a staff vaccination waiver (“Staff Vaccination Rule”).
The status and changes to each of these rules are summarized below.
LTC testing and Medicare provider and provider staff vaccination rules
The new rule eliminates LTC testing requirements by eliminating the COVID-19 testing provisions that were codified in 42 CFR § 483.80(h) by the LTC Testing Interim Rule. CMS explains that those testing requirements have not been and are no longer applicable after PHE ended on May 11, 2023. Likewise, the new rule rolls back regulatory provisions that mandate COVID-19 vaccination policies and procedures for staff health care pursuant to the Staff Vaccination Rule.
As a result, covered Medicare and Medicaid providers and providers are no longer required to comply with staff immunizations, COP tracking and documentation, CfC, and the requirements created by the Staff Immunization Rule, and LTC facilities are no longer subject to the standards mandatory personnel tests. However, as discussed below, vaccination education and delivery standards still apply to LTC facilities and ICF-IIDs.
The new rule emphasizes that ending CMS’s COVID-19 staff vaccination and LTC facility testing requirements does not prohibit healthcare facilities from imposing similar requirements on their own, and CMS encourages healthcare employers to maintain “policies based on Evidence” regarding the vaccination of staff for COVID-19 and other communicable diseases. To that end, CMS said it plans to support COVID-19 vaccinations through quality standards and other regulatory mechanisms, which are currently under development.
For example, CMS is considering adopting, through future regulation, certain Medicare quality program standards regarding COVID-19 immunization measures and publicly reported performance information under the Medicare program, including the system of merit-based incentive payments (MIPS). Accordingly, regulated entities should monitor any regulation or guidance by CMS addressing new COVID-19 vaccination quality measures and other quality-based vaccination initiatives.
Note that the Staff Immunization Rule and its revocation do not directly apply to or affect other employers or entities, including other health care entities, such as physicians’ offices, that are not regulated by CMS. In addition, the repeal of LTC testing and personnel vaccination policies does not alter compliance with applicable state or local laws that mandate COVID-19 vaccination and related requirements on healthcare facilities, providers, and/or regulated providers.
COVID-19 vaccination education and supply rule
As noted above, CMS issued a rule in May 2021 requiring LTC and ICFs-IID facilities to provide COVID-19 vaccination education and offer vaccines to residents, staff and customers. Under the newly issued rule, the provisional disclosure and offer requirements, codified in 42 CFR sections 483.80(d), 483.430(f), and 483.460(a)(4), are now being finalized on an ongoing basis.
As such, LTC facilities must comply with infection control requirements, for example, immunization education and supply processes pursuant to 42 CFR § 483.80(d), to participate in Medicare and Medicaid programs; and ICFs-IIDs must comply with facility personnel COVID-19 vaccination and vaccination education and provision processes (pursuant to 42 CFR §§ 483.430(f), 483.460(a)(4)) to participate in Medicare programs and Medicaid in the future.
As a result, LTC facilities and ICF-IIDs will need to continue to monitor and maintain continued compliance with these immunization education and provision requirements, even after PHE ends. Additionally, CMS does not allow personnel to refuse COVID-19 vaccination under its education and supply provisions, explaining that such authorization could conflict with state laws requiring vaccination and would contradict the overall goals of protecting health. health and safety of residents, customers and staff under the Rule.
In response to the comments, CMS affirms the importance of education and provision requirements as essential to “ensuring populations at highest risk of infection continue to be prioritized and receive timely preventive care during the COVID-19 pandemic “. CMS also notes concern about failure to meet provisional offer and instruction requirements as another reason driving its decision to finalize those regulations. The education and supply requirements apply to all LTC and ICFs-IID facility personnel (whether or not a “W-2” relationship exists), which includes any person who works in a facility at least once a week. The new rule also clarifies that these requirements extend to “individuals who may not be physically in the LTC facility for a period of time due to illness, disability or planned time off, but who are expected to return to work.” Therefore, LTC and ICFs-IID facilities should ensure that staff with anticipated changes in work arrangements, such as staff who will stop working remotely, receive vaccination education and offer services in accordance with this rule, as appropriate. cases.
Reed Smith will continue to monitor developments regarding COVID-19 personnel vaccination and testing requirements, from both CMS and the Department of Labor.
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