CMS Rule Dramatically Expands COVID-19 Vaccination Mandates for Medicare and Medicare-Certified Healthcare Facilities

On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an anticipated interim final rule (the “CMS Vaccine Rule”) that will require COVID-19 vaccination for most health care workers at certain healthcare facilities certified by CMS. CMS has also published a series of FAQs on the Rule. Intended to be “complementary” to an OSHA emergency rule issued on the same day that applies to employers of 100 or more workers, the CMS Vaccine Rule applies stricter standards in covered healthcare facilities. Sands Anderson’s analysis of the OSHA large employer rule is available here. The CMS Vaccine Rule will become effective November 5, 2021, and covered healthcare facilities have only until December 6, 2021 to establish a policy for all staff to be fully vaccinated on or before January 4, 2022.

UPDATE: As a result of litigation, the CMS vaccine mandate is currently enjoined and not enforceable in 25 states. Where the rule is currently enforceable, including Virginia, CMS has announced its intention to enforce the rule under modified compliance timeframes. Please review our latest article for up to date information about the current enforcement dates.

What Is Required Under the CMS Vaccine Mandate?

The CMS Vaccine Rule requires covered facilities to establish a policy requiring that all eligible staff receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 6, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by January 4, 2022. At this time, the Rule only requires that workers receive the “primary” vaccine doses and does not require staff to obtain booster doses.

Compared to the new OSHA large employer rule that allows employers to offer workers the option of weekly COVID-19 testing in lieu of vaccination, healthcare workers in facilities covered by the CMS Vaccine Rule will not have this option. CMS has explained that it holds healthcare providers to a higher standard than other employers. The regulation does provide for exemptions based on recognized medical conditions or religious beliefs, observances, or practices. Facilities must develop a similar process or plan for permitting exemptions in alignment with current federal law. For example, healthcare providers should remain familiar with current EEOC guidance addressing medical and religious exemptions. Below is a summary of additional key features of the new regulation:

What Healthcare Facilities Must Implement a Vaccine Mandate?

The CMS Vaccine Rule mandate applies only to the following facilities certified by CMS and subject to Medicare Conditions of Participation, Conditions for Coverage, or Requirements for Participation:

• Ambulatory Surgical Centers
• Hospices
• Programs of All-Inclusive Care for the Elderly
• Hospitals
• Long Term Care Facilities
• Psychiatric Residential Treatment 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 supplier
• Rural Health Clinics/Federally Qualified Health Centers
• End-Stage Renal Disease Facilities

The CMS Vaccine Rule does not apply to many other settings, including private physician or dental offices, state-licensed assisted living facilities, group homes, or to other settings not already subject to CMS health and safety regulations. It also does not apply to religious nonmedical healthcare institutions, organ procurement organizations or portable X-ray suppliers. Facilities and healthcare providers not listed above are not subject to the new CMS Vaccine Rule but may be subject to OSHA’s new large employer rule. In addition to the new vaccine mandate, many healthcare providers must continue to follow OSHA’s previous COVID-19 Healthcare Emergency Temporary Standard issued in June 2021. That rule remains in effect (see Sands Anderson summary of the June 2021 OSHA ETS).

Which Staff Are Covered?

The CMS Vaccine Rule requires covered healthcare facilities to mandate vaccination for all staff who provide care, treatment, or other services for the facility and/or its patients. The vaccine mandate applies to all staff of a covered facility, regardless of patient contact or location, and is not limited to individuals who are present within a covered healthcare facility or who are at the physical site of patient care. This expressly includes administrative staff, facility leadership, volunteer or other fiduciary board members, housekeeping and food services, and others. Under the Rule, any individual (employee, contractor, or otherwise) who performs duties at any site of care, or who has the potential to have contact with anyone at the site of care, including other staff, must be vaccinated.

The CMS Vaccine Rule does note that those staff members who telework 100% of the time do not need to be vaccinated. In addition, vendors, volunteers, and professionals who provide “one off” services at covered facilities are not required to be vaccinated. Specific examples include an annual elevator inspector or delivery and repair personnel. CMS notes that, in determining whether an individual falls into a category that requires vaccination, facilities should consider frequency of presence, services provided, and proximity to patients and staff. CMS notes that a plumber making an emergency repair in an empty restroom may not be an appropriate candidate for mandatory vaccination, while a construction crew using shared facilities during breaks may be subject to the requirements.

In crafting an appropriate policy, covered healthcare facilities will need to take into account a number of nuances and considerations noted in the CMS Vaccine Rule to determine which individuals are covered under the new Rule.

How Will the CMS Vaccine Mandate Be Enforced?

CMS will rely on existing enforcement processes, including onsite surveys. CMS expects that State Survey Agencies (including the Virginia Department of Health, Office of Licensure and Certification) will assess facilities for compliance with the new Rule during standard recertification surveys and during complaint surveys. Survey teams are expected to review a facility’s COVID-19 vaccination policies, the number of resident and staff COVID-19 cases over the prior four-week period preceding a survey, and a list of all staff and their vaccination status.

Healthcare facilities found out of compliance with the CMS Vaccine Rule could face penalties in line with existing available penalties for other types of non-compliance, including civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid programs.

Conclusion

Healthcare facilities covered by the new CMS Vaccine Rule should take steps now to implement an appropriate policy in advance of the December 6, 2021 deadline. Healthcare providers should also be aware of additional requirements under OSHA’s new large employer vaccine mandate, the June 2021 OSHA ETS covering healthcare providers, and Executive Orders covering federal employees and contractors.