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Interim Final Rule Expected in October to Mandate Vaccines in Most Health Care Settings

on Monday, 13 September 2021 in Covid-19 Information Hub

Along with President Biden’s September 9th announcement that he directed OSHA to issue an Emergency Temporary Standard (ETS) requiring vaccinations for all employers with over 100 employees, he also announced that his administration will require COVID-19 vaccination of staff within all Medicare and Medicaid-certified facilities.  To carry out this requirement, the Centers for Medicare & Medicaid Services (CMS), in collaboration with the Centers for Disease Control and Prevention (CDC), announced that the emergency regulations previously in development for nursing facilities will be expanded to include hospitals and other CMS-regulated settings as a condition for participating in the Medicare and Medicaid programs.  The regulations will be in the form of an Interim Final Rule with comment period and are targeted for publication in October.

While it is not entirely clear how expansive the mandate will be, the CMS press release listed as examples dialysis facilities, ambulatory surgical settings, and home health agencies.  The White House press release indicated the requirement will apply to:

“clinical staff, individuals providing services under arrangements, volunteers, and staff who are not involved in direct patient, resident or client care.  These requirements will apply to approximately 50,000 providers and cover a majority of health care workers across the country.”

So who may not be on the list?  It is unclear if or how the new regulations will reach medical practices or other providers that currently are not subject to conditions of participation in regulatory form.  Many of those providers, however, will attend to patients in a facility covered by the anticipated regulations.

It is also unclear whether the regulations will provide for exemptions for medical reasons and accommodations consistent with the Equal Employment Opportunity Commission (EEOC) guidelines for employees who have a sincerely held religious belief, practice or observance against vaccination, as have been implemented by most employers who have previously mandated vaccines.

While many health care organizations in larger metropolitan areas have mandated vaccines, many facilities in rural communities have not over concerns of available staffing.  The American Hospital Association issued a statement noting that “as a practical matter, this policy may result in exacerbating the severe workforce shortage problems that currently exist” and called on Biden’s Administration to help develop strategies to “ensure that hospitals and health systems on the front lines…have the necessary human resources to both win this battle and maintain essential health services for the patients and communities we serve.”[1]  While the industry awaits the details of the regulations, the debate about vaccine mandates in health care settings is likely to get even louder.



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