This article was updated on January 24, 2022, to reflect updated implementation dates in some states.
On January 13, 2022, the Supreme Court issued dual decisions impacting the CMS (Centers for Medicare & Medicaid Services) and OSHA (Occupational Safety and Health Administration) vaccine mandates in Biden v. Missouri and NFIB V. OSHA. The decisions granted a stay as to the preliminary injunctions of two district courts against CMS’ Interim Final Rule (“IFC”) and determined a stay of OSHA’s Emergency Temporary Standard (“ETS”) was justified—effectively allowing the CMS-vaccine mandate to proceed while blocking implementation of the OSHA ETS. Butler Snow’s Labor & Employment Practice Group has published a separate and informative alert addressing the OSHA ruling, read it here.
Biden v. Missouri
In a per curiam decision, the Supreme Court ruled that it had no grounds “for limiting the exercise of authorities [CMS] has long been recognized to have,” relying on both the agency’s responsibility to protect patient safety as well as several Medicare statutes allowing for the imposition of “other requirements” relating to the health and safety of patients. Noting that CMS routinely imposes conditions of participations relating to the qualifications and duties of healthcare workers, the Court found the agency’s reasoning for the mandate persuasive and akin to past Medicare requirements governing the safe and effective provision of health care. The Court thus held that the Secretary had not exceeded his statutory authority, and further dismissed the procedural argument that the two months taken to promulgate the IFC constituted “delay” inconsistent with the Secretary’s finding of good cause to forego a notice-and-comment period. Notably, both Justices Thomas and Alito issued separate dissents, joined by one another and Justices Barrett and Gorsuch, with Thomas’ dissent aimed at the lack of explicit statutory authority for the mandate and Alito’s finding that the Secretary had failed to show good cause to skip the notice-and-comment requirement.
Considering this momentous decision and CMS’ most recent guidance setting forth new deadlines for implementation of its vaccine mandate, health care providers must act quickly to ensure compliance and avoid potential penalties. Here is a quick summary of the 200 + page rule and its application:
The CMS Rule – Redux
On November 5, 2021, CMS published an Interim Final Rule, with comment period, 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.
Facilities Covered
The IFC applies to:
- Ambulatory Surgical Centers (ASCs)
- Hospices
- 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.
Individuals Covered
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.” According to CMS guidance, physicians with admitting privileges and/or treating patients in-person with a facility subject to the IFC “must be vaccinated so that the facility is compliant.”
Implementation and Timing
Update: On January 20, 2022, CMS issued additional guidance for Texas, which filed a motion to dismiss its case without prejudice that was subsequently granted on January 19, 2022. Texas providers subject to the IFC shall have until February 22, 2022 to comply with Phase 1 and March 21, 2022 to comply with Phase 2.
Update: On January 14, 2022, CMS issued new guidance in which states previously subject to the stayed injunctions would have until February 14, 2022, to comply with Phase 1 and March 15, 2022, to comply with Phase 2. These states include Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia and Wyoming. All other states—except Texas, which is subject to a separate injunction that was not before the Supreme Court—will be expected to comply with the dates set forth below.
The IFC is to be implemented in two distinct phases:
Phase 1: By January 27, 2022 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. In addition, facilities must develop and implement policies and procedures for ensuring all facility staff, “regardless of clinical responsibility or patient or resident contact are vaccinated….”
Phase 2: By February 28, 2022 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).
Exemptions
CMS requires facilities to allow for exemptions for 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.”
Enforcement
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.
Butler Snow’s Health Law and Labor & 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:
Guidance for the CMS Interim Final Rule: CMS Guidance
CMS Frequently Asked Questions: FAQ
