CMS Issues Emergency Regulation Implementing Vaccine Mandate for Healthcare Providers and Suppliers

On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with comment period establishing COVID-19 vaccine requirements for staff and others at most Medicare and Medicaid certified providers and suppliers. Those individuals covered by the rule will need to be fully vaccinated by January 4, 2022, unless they receive a religious or medical exemption.

The scope of the interim final rule is broad extending to most institutional Medicare and Medicaid certified providers and suppliers, including the following: ambulatory surgical centers, hospices, psychiatric residential treatment facilities, Programs of All-Inclusive Care for the Elderly or PACE programs, hospitals, long term care facilities, intermediate care facilities for individuals with intellectual disabilities, home health agencies, comprehensive outpatient rehabilitation facilities, critical access hospitals, clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech language pathology services, community mental health centers, home infusion therapy suppliers, rural health clinics and federally qualified health centers, and end-stage renal disease facilities. The interim final rule requires that all of the foregoing providers and suppliers develop and implement policies and procedures under which all staff are vaccinated for COVID-19.

Equally notable is the expansive approach taken in the interim final rule to identify those staff members subject to the new vaccine mandate. In particular, the rule requires that:

“Each facility’s COVID-19 vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients: facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement. These requirements are not limited to those staff who perform their duties within a formal clinical setting, as many healthcare staff routinely care for patients and clients outside of such facilities, such as home health, home infusion therapy, hospice, PACE programs, and therapy staff. Further, there may be staff that primarily provide services remotely via telework that occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a healthcare facility or site of care for their job responsibilities.”

As such, the interim final rule provides that it will be necessary for Medicare and Medicaid certified providers and suppliers to require vaccination for all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location regardless of frequency of patient contact, and not just to those who physically enter facilities, clinics, homes, or other sites of care. The vaccine mandate extends to administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services, and others that meet the criteria of the rule. In addition, each covered entity is now required to develop and implement policies and procedures for all staff to be vaccinated for COVID-19.

However, CMS also recognized in the interim final rule that there are many infrequent services and tasks performed in or for a healthcare facility by vendors, volunteers, and professionals for specific limited purposes and for a limited amount of time. Providers and suppliers are not required to ensure the vaccination of those who infrequently provide “ad hoc non-healthcare services (such as an annual elevator inspection), or services that are performed exclusively off-site, not at or adjacent to any site of patient care (such as accounting services), but they may choose to extend COVID-19 vaccination requirements to them if feasible.” The interim final rule also expressly makes it clear that the vaccine mandate does not apply to every individual who enters a facility, although it is also clear that CMS does not intend to prohibit any such extension of the mandate requirement. However, CMS also clarified that the mandate does not extend to individuals who provide services only on a remote basis, such as fully remote telehealth or payroll services.

According to a press release issued in connection with the interim final rule, those Medicare and Medicaid certified providers and suppliers covered by the new CMS rule will not have to also comply with the vaccination rules for large employers recently issued by the Occupational Safety and Health Administration.

Medicare and Medicaid certified providers and suppliers should promptly begin to prepare their plans for complying with the new vaccine mandate, as CMS only allowed a sixty day period to achieve compliance. Statements issued by CMS in connection with the issuance of the interim final rule strongly suggest that CMS will have little tolerance for those who fail to adhere.

Buchanan’s healthcare and labor attorneys, as well as government relations professionals, are prepared to discuss the risks and necessary steps to implement the new CMS and OSHA mandatory policies and procedures.