On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an Interim Final Rule, with comment period (IFC), mandating that most Medicare and Medicaid-certified providers and suppliers take steps to ensure that all staff at the included healthcare facilities are vaccinated for COVID-19. The following is brief summary of the 200+ page rule.
The IFC applies to:
- Ambulatory Surgical Centers (ASCs)
- Psychiatric residential treatment facilities (PRTFs)
- Programs of All-Inclusive Care for the Elderly (PACE)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
- Home Health Agencies (HHAs)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs)
- Critical Access Hospitals (CAHs)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services
- Community Mental Health Centers (CMHCs)
- Home Infusion Therapy (HIT) suppliers
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) and
- End-Stage Renal Disease (ESRD) Facilities.
However, the IFC does not apply to other health care entities, including physician offices.
The IFC requires all applicable providers and suppliers to “develop and implement policies and procedures under which all staff are vaccinated for COVID-19.” “Staff” is broadly defined in the mandate to include:
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 arrangements.
The mandate is not limited to staff who perform their duties within a formal clinical setting. Rather, the IFC also applies to staff who work offsite, described in the rule as “all staff that interact with other staff, patients, residents, clients, or PACE program participants in any location, beyond those that physically enter facilities, clinics, homes, or other sites of care.” Exempted, however, are individuals who provide services “100 percent remotely….”
Also included within the IFC are those who provide services directly, on a regular basis, at the covered facilities, including “individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, social workers, and portable x-ray suppliers.”
Implementation and Timing
The IFC is to be implemented in two distinct phases:
Phase 1: By December 5, 2021 (within 30-days after the regulation is published), staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its patients.
Phase 2: By January 4, 2022 (within 60-days after publication), staff at all health care provider and supplier types included in the regulation must complete the primary vaccination series (except for those who have been granted exemptions from the COVID-19 vaccine or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC). The completion of a primary vaccination series for COVID-19 is defined in the rule as the administration of a single-dose vaccine (such as the Janssen (Johnson & Johnson) COVID-19 Vaccine), or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 Vaccine (interchangeable with the licensed Comirnaty Vaccine) or the Moderna COVID-19 Vaccine).
CMS requires facilities to allow for exemptions to staff with recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act (ADA)) or religious beliefs, observances, or practices (established under Title VII of the Civil Rights Act of 1964). CMS’s FAQ guidance on the IFC, although recognizing these exemptions, emphasizes that “no exemption should be provided to any staff for whom it is not legally required (under the ADA or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination.”
According to the IFC, CMS intends to enforce the vaccine mandate through existing State survey procedures. Surveyors will be trained on the requirements of the new IFC and the agency promises to publish new guidance for surveyors, providers, and suppliers affected by the new rules. As with other CMS rules, noncompliance could subject providers and suppliers to a range of remedies, including civil money penalties, denial of payment for new admissions/patients, or termination of the Medicare/Medicaid provider agreement.
In response to a lawsuit brought by a number of states and private entities, the Fifth Circuit Court of Appeals recently issued a stay preventing enforcement of the Occupational Safety and Health Administration’s (OSHA) Emergency Temporary Standard, a similar vaccine mandate applicable to workplace settings. On November 10, 2021, a multi-state coalition of Attorney Generals filed suit to challenge the mandate in the United States District Court for the Eastern District of Missouri. Additional lawsuits are expected. Butler Snow’s Health Law and Employment Law attorneys are following developments closely and will update this post as events warrant.
In the meantime, these links can be accessed for additional information:
The CMS Interim Rule: Federal Register
CMS Frequently Asked Questions: CMS FAQ