Almost two years after issuing its Interim Final Rule requiring COVID-19 vaccination for certain health care works, the Centers for Medicare and Medicaid Services (“CMS”) has issued a final rule addressing several regulations regarding COVID-19 vaccination, testing, and education requirements in health care facilities.
In short, the rule eliminates the COVID-19 vaccine requirement for staff at certain categories of Medicare-participating health care providers and ends COVID-19 vaccination testing requirements for staff at long-term care (“LTC”) facilities. Additionally, the rule finalizes previously interim provisions regarding COVID-19 vaccination “educate and offer” requirements for residents, staff, and clients at LTC facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (“ICFs-IID”).
The rule states that rolling back COVID-19 vaccination and testing requirements enacted during the pandemic aligns with the end of Public Health Emergency (“PHE”) on May 11, 2023 and the concomitant reduction in infection rates, decline in deaths, and significant vaccination uptake by the public.
Although rules generally take 60 days after the date of publication in Federal Register to become effective, CMS says it will exercise enforcement discretion for compliance with the rescinded vaccination rules between now and that anticipated date—August 4, 2023—in other words, compliance with these requirements is no longer necessary as of the date of the rule’s publication on June 5, 2023.
New rule changes three pandemic-era rules
The rule has a combined effect on three pandemic-era rules that were put in place to help stem the spread of COVID-19 through vulnerable populations in health care facilities:
- The first rule issued in September 2020 as an interim final rule with comment period pertained to COVID-19 testing requirements at LTC facilities (“LTC Testing Rule”). This rule, among other things, mandated that LTC facilities routinely test residents and staff for COVID-19. See 42 CFR § 483.80(h).
- The second rule issued in May 2021 revised requirements for LTC facilities and conditions of participation (“CoPs”) for ICFs–IID, requiring these facility types to provide COVID-19 vaccine education and offer vaccinations to personnel, clients, and residents (“Educate and Offer Rule”); CMS also revised infection control requirements for LTC facilities to include COVID–19 data reporting as part of this rulemaking.
- The third rule was published in November 2021 as an interim final rule and imposed COVID-19 staff vaccination requirements and conditions for coverage (“CfCs”) on specific Medicare and Medicaid providers and suppliers, which included requirements to track and document staff vaccination status and establish a process by which staff could request an exemption from vaccination (“Staff Vaccination Rule”).
The status of and changes to each of these rules are summarized below.
LTC Testing and Medicare Provider and Supplier Staff Vaccination Rules
The newly issued rule eliminates the LTC testing requirements by deleting the COVID-19 testing provisions that had been codified under 42 CFR § 483.80(h) by the interim LTC Testing Rule. CMS explains that such testing requirements have not been and are no longer applicable after the PHE ended on May 11, 2023. Similarly, the new rule withdraws regulatory provisions mandating COVID–19 vaccination policies and procedures for health care staff under the Staff Vaccination Rule.
Accordingly, covered Medicare and Medicaid providers and suppliers are no longer required to comply with staff vaccination, tracking, and documentation COPs, CfCs, and requirements created by the Staff Vaccination Rule, and LTC facilities are no longer subject to mandatory staff testing standards. However, as discussed below, vaccination education and offer standards still apply to LTC facilities and ICFs-IID.
The new rule stresses that ending CMS’s COVID-19 staff vaccination and LTC facility testing requirements does not prohibit health facilities from imposing similar requirements on their own, and CMS encourages health care employers to maintain “evidence-based policies” regarding staff vaccination 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 being developed.
For example, CMS is considering adopting, through future rulemaking, certain Medicare quality program standards regarding COVID–19 vaccination measures and publicly reported performance information under the Medicare program, including the Merit-Based Incentive Payment System (MIPS). Accordingly, regulated entities should monitor for any rulemaking or guidance from CMS addressing new COVID-19 vaccination quality measures and other quality-based vaccination initiatives.
Of note, the Staff Vaccination Rule and its rescission do not directly apply to or effect other employers or entities, including other health care entities, such as physician offices, which are not regulated by CMS. Further, the recession of the LTC Testing and Staff Vaccination Rules do not alter compliance with applicable state or local laws that impose COVID-19 vaccination and related requirements on regulated health care facilities, providers, and/or suppliers.
COVID-19 Vaccination Education and Offer Rule
As noted above, CMS issued a rule in May 2021 requiring LTC facilities and ICFs-IID to provide COVID–19 vaccination education and to offer vaccines to residents, staff, and clients. Pursuant to the newly issued rule, the interim education and offer requirements—codified under 42 C.F.R. Sections 483.80(d), 483.430(f), and 483.460(a)(4)—are now being finalized on a permanent basis.
As such, LTC facilities must comply with infection control requirements, i.e., vaccination education and offer processes under 42 C.F.R. § 483.80(d), to participate in the Medicare and Medicaid programs; and ICFs-IID must comply with COVID-19 vaccination of facility staff and vaccination education and offer processes (under 42 C.F.R. §§ 483.430(f), 483.460(a)(4)) to participate in the Medicare and Medicaid programs moving forward.
Consequently, LTC facilities and ICFs-IID will need to continue to monitor and maintain ongoing compliance with these vaccination education and offer requirements, even after the end of the PHE. Further, CMS does not allow staff to reject COVID-19 vaccination under the education and offer provisions, explaining that such a permission could conflict with state laws requiring vaccination and would contradict the overarching goals of protecting the health and safety of residents, clients, and staff under the Rule.
In response to comments, CMS affirms the importance of education and offer requirements as essential to “ensuring that populations at higher risk of infection continue to be prioritized and receive timely preventive care during the COVID–19 pandemic.” CMS also notes concern regarding non-compliance with the interim education and offer requirements as another reason driving its decision to finalize such regulations. The education and offer requirements apply to all LTC facility and ICFs–IID staff (regardless of whether there is a “W-2” relationship), which includes any person who works in a facility at least once per week. The new rule further 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 scheduled time off, but who are expected to return to work.” As such, LTC facilities and ICFs-IID should ensure that staff with anticipated changes in work arrangements—e.g., staff who will stop working remotely—receive vaccination education and offer services in compliance with this rule, as appropriate.
Reed Smith will continue to monitor developments with regard to COVID-19 staff vaccination and testing requirements, both from CMS and from the Department of Labor. If you have any questions about this rule, please reach out to the health care lawyers at Reed Smith.