On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim decision to reign which requires most Medicare and Medicaid certified providers and providers to immunize staff members within 60 days. The rule even covers staff members who do not have direct patient contact, but includes some limited exemptions for staff who provide support services exclusively outside the facility.
Who must comply with the rule?
The new rule applies to specific categories of providers who participate in the Medicare and Medicaid program: outpatient surgery centers; hospices; residential psychiatric treatment establishments; all-inclusive care programs for the elderly (PACE programs); hospitals (including acute care hospitals, mental hospitals, long-term care hospitals and children’s hospitals); long-term care facilities (including skilled nursing facilities and nursing homes); intermediate care facilities; home health agencies; comprehensive outpatient rehabilitation facilities; critical access hospitals; clinics, rehabilitation agencies and public health agencies as providers of outpatient physiotherapy and speech therapy services; community mental health centers; home infusion therapy providers; rural health clinics; health centers approved by the federal government (FQHC); and end-stage kidney disease treatment facilities.
The rule requires providers to develop policies and procedures to ensure that all staff are fully immunized against COVID-19. Policies and procedures should apply to facility staff who, regardless of clinical responsibility or patient contact, provide care, treatment or other services to the facility or its patients. This includes employees, licensed practitioners, students, interns, and volunteers. In particular, the policy must also apply to persons who provide care, treatment or other services to the establishment or its patients, under a contract or other arrangement.
CMS also expresses its intention that the rule pre-empt national and local laws that would prohibit health facilities from complying with a vaccination mandate.
Who is exempt from the rule?
The new rule does not apply to providers who do not participate in the Medicare or Medicaid program. The rule also does not apply directly to physician offices, organ procurement organizations, assisted living facilities, group homes, or home and community service providers. However, CMS noted in developing the rules that employees of these organizations may be subject to vaccine requirements through service agreements with regulated suppliers. For example, doctors who have medical personnel privileges in a hospital should be vaccinated against COVID-19.
A facility that is required to develop and implement a COVID vaccination policy is permitted to exclude certain categories of staff from the policy. Staff who exclusively provide telehealth or telemedicine services outside the hospital setting and do not have direct contact with patients and other staff do not need to be covered by the policy. In addition, staff who provide services for the establishment that are carried out exclusively outside the establishment and who do not have direct contact with patients and other staff members subject to the vaccination mandate do not does not need to be taken into account by politics.
CMS suggests that when determining whether to require vaccination against COVID-19 of a person who does not fit into the above categories, establishments should consider three elements: (1) the frequency of attendance, (2) services provided and (3) proximity to patients and staff.
What does the rule require?
There are three basic requirements of the new CMS rule. Facilities subject to the new CMS rule must: (1) develop a process or plan to immunize all eligible staff against COVID-19, (2) develop a process or plan to provide exemptions and housing to members of the staff who are eligible for an exemption from the COVID-19 vaccine requirement, and (3) develop a process to track and document staff vaccinations and exemptions.
Facilities must develop a staff immunization plan by December 5, 2021. In addition, by December 5, 2021, staff in all facilities must receive a first dose of the primary series for a vaccine. multidose COVID-19 before staff. provide care, treatment or other services for the facility. By January 4, 2022, all facility staff, except those who have been granted exemptions, must be fully immunized against COVID-19. Staff who have completed the primary series for vaccine received before the implementation date of January 4, 2022 are considered to have met CMS requirements, even if the staff member has not yet completed the period of 14 day wait required for full vaccination.
Can the establishment allow exemptions for staff members?
The facility’s COVID-19 plan must allow medical and religious exemptions from the vaccine, according to federal law. For staff members requesting medical exemption, documentation must be signed and dated by a licensed practitioner. The facility should also establish an emergency plan for staff members who are not fully vaccinated against COVID-19.
CMS considered allowing facilities to require daily or weekly testing of unvaccinated people, but decided not to require such testing. Facilities may implement testing precautions in addition to vaccination requirements. However, as currently written, vaccination against COVID-19 is the only option (unless a staff member is eligible for a medical or religious exemption), and testing is not an alternative to vaccination. .
Other vaccination mandates
It is important to note that although an entity may be exempted or not required to meet CMS vaccination requirements, entities may still be subject to other state and federal COVID-19 vaccination requirements, such as those issued by the Occupational Safety and Health Administration. (OSHA).