Affected healthcare providers may be surprised by the November 2021 Interim Final Rule with Comments (IFR) that effectively enforced vaccination authorization for staff through the Centers for Healthcare and Medicaid Services (CMS) Quality and Safety Group Memorandum of October 26, 2022 (QSO)-23 -02-ALL) (Updated QSO Note), which provides surveyors with newfound flexibility in determining levels of non-compliance with the IRC. This shift in approach is attributed to national efforts to achieve a high level of vaccination and relatively low levels of hospitalization and death from SARS-CoV-2, the virus that causes COVID-19.
For hospitals, critical access hospitals, ambulatory surgery centers, hospice providers and other covered providers other than long-term care facilities and skilled nursing facilities, surveyors may now refer to non-compliance at a level below ‘status’ in the absence of ‘flagrant non-compliance’.
While new guidance from CMS continues to identify less than 100% of vaccinated employees or the absence of a single vaccination policy as “non-compliance,” surveyors are required to look for blatant non-compliance and a lack of “good faith” efforts to comply before citing a finding on Case level, the type of which would lead to the need for a correction plan and follow-up survey activity. ‘Fatal non-compliance’ is described as a circumstance…
- … like completely ignoring [CMS vaccination mandate] Requirements … More than 50% of employees are not immune (unless they are relieved, or temporarily delayed), and/or policies and procedures are not implemented as required.
For long-term care facilities and skilled nursing facilities, the updated QSO memorandum states that facilities that are not in compliance but have “implemented a plan to achieve” a 100% vaccination rate for employees will not be subject to enforcement action. Surveyors are required to cite the severity level and scope of non-compliance with F888 (relating to compliance with vaccination and related requirements) at severity level 1, with a broad band, or “C.” Similar to the way the terminology is defined for hospitals and other types of service providers, blatant non-compliance is described as “complete disregard for requirements” or “more than 50% of employees are unvaccinated” and without necessary policies and procedures in place.
Instead, surveyors of all types of providers covered are directed toward a more holistic approach that considers, regardless of staff compliance with vaccination, …
- … Infection prevention and control practices … such as proper use of personal protective equipment, transmission precautions that reflect current standards of practice, and/or other infection prevention and control practices designed to reduce transmission of COVID-19.
Previous guidelines, detailed in our previous book on the topic, included a more rigorous approach and, over time, in combination with government health care vaccination mandates, were sometimes identified as one of the basis for covered providers’ decisions to terminate unvaccinated employees (examples here and here) to avoid threats to private provider agreements them due to non-compliance.
Covered providers should assess their current compliance with CMS vaccination requirements in light of the updated QSO Memorandum and consider updating existing policies and procedures to reflect this change in approach and interpretation.