Earlier today, Argentum submitted formal comments in response to an interim final rule issued by CMS in May that would require congregate care facilities to educate all residents and staff about COVID-19 vaccines, offer vaccines to all residents and staff, and report certain data regarding vaccination and therapeutic treatments.
CMS released the rule in an effort to reach more individuals who are most risk of infection from COVID-19, specifically in long-term care facilities. According to CMS, despite numerous vaccine education programs, distribution efforts, and reporting requirements, efforts have not been universal and many at-risk individuals are unable to access vaccines.
The rule specifically applies to facilities under CMS's scope of regulatory authority, but the agency is considering applying the requirements to other Medicare/Medicaid participating shared residences, to potentially include assisted living facilities. The rule includes three major elements to better reach vaccine adoption by LTC residents and staff, which it is seeking public comment:
Offer and Provide COVID-19 Vaccine to LTC Residents and Staff. The rule requires facilities to develop and implement policies and procedures to ensure that they can offer residents and staff COVID-19 vaccines when vaccine supplies are available. LTC facilities may provide the vaccine directly or indirectly, such as through arrangement with a pharmacy partner or local health department. The rule requires the facility to maintain medical records on each resident that are complete and accurately documented, including whether such resident has refused the COVID-19 vaccine.
COVID–19 Disease and Vaccine Education. The rule requires facilities to educate staff on COVID-19 vaccines. CMS considers facility staff to be those individuals who work in the facility on a regular (i.e., at least once a week) basis, including individuals under a contract or other arrangement. Staff education must cover the benefits of vaccination and also address risks associated with vaccination, which should include potential side-effects of the vaccine. The rule also requires LTC facilities to educate residents or resident representatives on the COVID-19 vaccine.
Reporting. The IFC requires LTC facilities to, on a weekly basis, report to the CDC’s National Healthcare Safety Network (NHSN) the COVID–19 vaccination status and related data elements of all residents and staff.
In our comments, we reasoned that the requirements should not be extended to cover assisted living facilities that participate in Medicaid, as it would be overly burdensome and assisted living providers have successfully implemented COVID-19 mitigation policies and vaccine administration campaigns without the federal requirements. We further recommend that CMS make these programs for assisted living providers voluntary, to eliminate the threat of penalties for non-compliance and weekly reporting requirements, and to ensure that facilities most in need of vaccination resources would have the CMS resources as needed.
Our comments were developed by a representative group of Argentum members through a taskforce of the Legal and Government Relations Committee, with the assistance of our outside counsel.