Biden Administration Announces Upcoming Rules to Dramatically Expand Covid-19 Vaccination Mandates for Healthcare Providers

On September 9, 2021 President Biden announced a series of Executive Orders and upcoming regulations that expand mandatory vaccination requirements for COVID-19 and will apply to over 100 million U.S. workers, including mandates for all employers with over 100 workers, federal workers and contractors, and healthcare employers.

For healthcare employers, the Biden administration has announced an upcoming sweeping regulation that will require COVID-19 vaccinations for all workers in many healthcare settings that are certified by Medicare and Medicaid or, potentially, are not certified but that receive Medicare and Medicaid reimbursement. An Interim Final Rule implementing the mandate is expected in early October. Available press releases and information provide only the broad outlines of the upcoming rule:

• The mandate will likely apply to hospitals, nursing facilities and other long-term care facilities, dialysis facilities, ambulatory surgical settings, home health agencies, hospices, clinical labs, ambulance providers, among other providers who receive Medicare and Medicaid reimbursement, as a condition for participating in the Medicare and Medicaid programs.
• The expanded vaccination mandate is expected to cover over 50,000 health care organizations and over 17 million health care workers across the United States.
• The mandate will cover direct care staff and staff who are not involved in direct patient, resident, or client care.
• The mandate will apply broadly the workforce of covered settings, including employees, contractors, volunteers, and other staff of such institutions.

Current announcements from the White House and the Centers for Medicare and Medicaid Services (“CMS”) provide little additional information at this time and leave many unanswered questions. For example, will the mandate apply only to Medicare and Medicaid-certified “facilities,” or will it also apply to other healthcare provider organizations more broadly who receive Medicare and Medicaid reimbursement? CMS press has indicated that the rule would be focused on certified facilities, which are only a subset (albeit large) of the healthcare sector. In contrast, White House materials suggest that the rule could more broadly apply to other healthcare settings that receive Medicare or Medicaid reimbursement.

In addition, how will the mandate be implemented and enforced? What steps will employers need to take to verify employee vaccine status? Previous information from CMS to nursing facilities had indicated that medical and religious exemptions would still be available. CMS had also previously indicated that enforcement of a federal mandate would be handled through the existing survey and inspection process specific to nursing homes. While it may be reasonable to assume that the mandate could be enforced through existing inspection mechanisms already applicable to Medicare and Medicaid-certified providers, it is unclear how enforcement will be handled across provider types.

Healthcare providers should take steps now to begin planning for this new mandate. Healthcare providers should also be aware of coverage under the new large employer vaccine mandate under forthcoming OSHA rules and Executive Orders covering federal employees and contractors.