On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule that requires most Medicare and Medicaid certified providers and suppliers to vaccinate staff members within 60 days. The rule covers even those staff members who do not have direct patient contact, but includes some limited exemptions for staff who provide support services exclusively outside of the facility setting.
The new rule applies to specific categories of providers that participate in the Medicare and Medicaid program: ambulatory surgery centers; hospices; psychiatric residential treatment facilities; programs of all-inclusive care for the elderly (PACE programs); hospitals (including acute care hospitals, psychiatric hospitals, long term care hospitals, and children’s hospitals); long term care facilities (including skilled nursing facilities and nursing facilities); intermediate care facilities; 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; federally qualified health centers (FQHCs); and end stage renal disease facilities.
The rule requires providers to develop policies and procedures to ensure that all staff are fully vaccinated for COVID-19. The policies and procedures must apply to facility staff who, regardless of clinical responsibility or patient contact, provide any care, treatment, or other services for the facility or its patients. This includes employees, licensed practitioners, students, trainees, and volunteers. Notably, the policy must also apply to individuals who provide care, treatment, or other services for the facility or its patients, under contract or by other arrangement.
CMS also expresses its intention that the rule preempt those state and local laws that would prohibit health care facilities from complying with a vaccine mandate.
The new rule does not apply to providers that do not participate in the Medicare or Medicaid program. The rule also does not directly apply to physician offices, organ procurement organizations, assisted living facilities, group homes, or home and community based service providers. However, CMS noted in the rulemaking that employees of these organizations may be subject to vaccine requirements through service agreements with regulated providers. For example, physicians who have medical staff privileges at a hospital would need to be vaccinated against COVID-19.
A facility that is required to develop and implement a COVID vaccination policy is allowed to exclude certain categories of staff members from the policy. Staff who exclusively provide telehealth or telemedicine services outside of the hospital setting and do not have any direct contact with patients and other staff do not need to be addressed by the policy. In addition, staff who provide services for the facility that are performed exclusively outside of the facility and who do not have direct contact with patients and other staff who are subject to the vaccine mandate do not need to be addressed by the policy.
CMS suggests when determining whether to require COVID-19 vaccination of an individual who does not fall into the above categories, the facilities should consider three elements: (1) frequency of presence, (2) services provided, and (3) proximity to patients and staff.
There are three basic requirements of the new CMS rule. Facilities subject to the new CMS rule must: (1) develop a process or plan for vaccinating all eligible staff against COVID-19, (2) develop a process or plan for providing exemptions and accommodations for staff members who are eligible for an exemption from the COVID-19 vaccine requirement, and (3) develop a process for tracking and documenting staff vaccinations and exemptions.
Facilities must develop a plan for vaccinating staff members by December 5, 2021. In addition, by December 5, 2021, staff at all facilities must receive a first does of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any 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 vaccinated for COVID-19. Staff who have completed the primary series for the vaccine received by the January 4, 2022 implementation date are considered to have met CMS requirements, even if the staff member has not yet completed the 14-day waiting period required for full vaccination.
The facility’s COVID-19 plan must allow for medical and religious exemptions to the vaccine, in accordance with federal law. For staff members seeking a medical exemption, documentation must be signed and dated by a licensed practitioner. The facility must also establish a contingency plan for staff members who are not fully vaccinated for COVID-19.
CMS considered allowing facilities to require daily or weekly testing of unvaccinated individuals, but decided not to require such testing. Facilities may implement testing precautions in addition to vaccination requirements. However, as currently written, vaccination for 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.
It is important to note that while an entity may be exempt or otherwise not be 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 Occupational Safety and Health Administration (OSHA). You can review Foley’s Labor & Employment groups’ perspective on OSHA’s Emergency Temporary Standards here.
In case you missed our webinar “Health Care Provider and Vendor CMS Vaccine Mandate Compliance Q&A,” a link to the program is included here. You should feel free to share with colleagues.
We noted during the program, this is a rapidly-developing area with a number of states challenging the federal regulations. For example, the most recent court action was issued after recording. State of Missouri v. Biden, Case No. 4:21-cv-01329-MTS (E.D.Mo. Nov. 29, 2021). This decision enjoined CMS from enforcing the rule in the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming pending a trial on the merits; though it did not restrict health care providers from voluntarily imposing mandatory vaccine policies for their workforce or contractors that are compliant with existing law. We will update clients and friends on these developments at www.healthcarelawtoday.com.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.