In conjunction with the release of OSHA’s COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS), on November 4, 2021 the Centers for Medicare & Medicaid Services (CMS) at the U.S. Department of Health and Human Services issued its expected interim final rule with comment period (IFC) requiring that health care workers at facilities participating in Medicare and Medicaid be fully vaccinated by January 4, 2022.
The IFC covers approximately 76,000 health care facilities and more than 17 million health care workers – the bulk of healthcare workers across the country. The health care facilities subject to the IFC are those 21 types of providers and suppliers subject to established health and safety standards, known as Conditions of Participation. These run the gamut and range from hospitals to hospices to federally qualified health centers to long term care facilities, including skilled nursing facilities and nursing facilities. These providers also include, among others, ambulatory surgical centers, psychiatric residential treatment facilities, home health agencies, and community mental health care centers. Significantly, the IFC does not apply to other healthcare entities, such as physician offices, that are not regulated by CMS.
CMS’s IFC requires vaccination for “all staff who interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities or other sites of patient care.” The IFC does not apply to those staff members who work 100 percent remotely and who do not have direct contact with patients or other staff. Moreover, the IFC applies to employees of these facilities regardless of whether their positions are clinical or non-clinical, and also includes students, volunteers, and others. The IFC requires that health care facilities that participate in Medicare or Medicaid ensure that all employees are fully vaccinated on or before January 4, 2022. “Fully vaccinated” means two doses of the Pfizer or Moderna vaccine or one dose of Johnson & Johnson. Booster shots are not mandated in the IFC.
Unlike the OSHA ETS which allows unvaccinated employees to wear a face mask and engage in weekly testing, CMS has said that healthcare employees will not have the option of regular Covid-19 testing. The IFC does provide for medical and religious exemptions and requires that providers and suppliers subject to the IFC establish and implement a process by which staff may request an exemption for COVID-19 vaccination requirements based on an applicable Federal law. The IFC specifically states that certain allergies, recognized medical conditions, or religious observances or practices may provide grounds for exemption. Providers and suppliers must have a process for collecting and evaluating these requests.
Providers subject to the IFC must implement its provision in two phases. Phase 1, requires that all staff have received, at a minimum, the first dose of a two-dose COVID-19 vaccine, or a one-dose COVID-19 vaccine, by December 5, 2021. Phase 1 also requires providers to develop appropriate policies to implement the IFC. Phase, 2, effective on January 4, 2022, consists of the requirement that all applicable staff are fully vaccinated for COVID-19, except for staff who have been granted an exemption.
For those healthcare facilities out of compliance with the IFC, CMS has stated it will impose consequences ranging from civil monetary penalties to cessation of Medicare program participation. CMS will monitor compliance with the IFC through onsite inspections by its state survey agencies. For any businesses that are subject to both the OSHA ETS and the IFC (i.e., healthcare businesses with 100 or more workers), the IFC will apply and supersedes the OSHA ETS and other applicable state and local laws. The IFC also delays the requirement for federal contractors to get vaccinated from December 8, 2021 to January 4, 2022 to align with the IFC and ETS.
The IFC signals CMS’ firm stance on immediate implementation of its provisions. Those interested have 60 days to provide comments on the rule. While CMS has gone to great lengths to set forth the authority and background to the IFC, we expect legal challenges to it. We will continue to monitor developments and update this alert.