Biden Administration Requires Vaccination for Medicare and Medicaid Certified Providers/Suppliers by January 2022: CMS Issues its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule
Overview
The Centers for Medicare and Medicaid Services (CMS) issued its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) on November 4, 2021, the same day the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS). The IFR and ETS complement each other, with both aimed at furthering the Biden Administration’s goal of vaccinating the entire United States healthcare workforce to ensure capacity to serve local and national healthcare needs, the safety of the workforce and patients, and to reduce the risk of continued COVID-19 transmission. Both rules are effective November 5, 2021.
The ETS requires employers with 100 or more employees to have their employees fully vaccinated by January 4, 2022 and requires unvaccinated employees to produce a negative test on at least a weekly basis. It generally applies to all workplace settings where any employee provides health care services or health care support services. However, because the ETS targets settings where care is provided for individuals with known or suspected COVID-19, the rule contains several exceptions (e.g., health care support services not performed in a health care setting, telehealth services performed outside of a setting where direct patient care occurs, dispensing of prescriptions by pharmacists in retail settings).
Consequently, there is a significant gap in ensuring the vaccination of our entire healthcare workforce under the ETS. This gap will be significantly reduced per the IFR.
General Rule
Regardless of employer size, the IFR requires the following providers and suppliers, which are certified under the Medicare and Medicaid programs and regulated by the CMS health and safety standards (commonly known as the “Conditions of Participation,” “Conditions for Coverage”, or “Requirements for Participation”), to have all covered staff fully vaccinated by an FDA approved or authorized COVID-19 vaccine by January 4, 2022, absent legal exemption:
ambulatory surgery centers, hospices, psychiatric residential treatment facilities, programs of all-inclusive care for the elderly (PACE), hospitals, long term care facilities, intermediate care facilities for individuals with intellectual disabilities, home health agencies, comprehensive outpatient rehabilitation facilities, critical access hospitals, outpatient physical therapy and speech-language pathology service entities, community mental health centers, home infusion therapy suppliers, rural health clinics and federally qualified health centers, and end-stage renal disease facilities (collectively, the “Covered Providers”).
The IFR does not directly apply to other health care entities, such as physician offices, that are not regulated by CMS. CMS acknowledges the limits of its authority and comments that States have separate licensing requirements for health care staff and health care providers applicable to physician office staff and other staff in small health care entities, which it hopes will help close the healthcare workforce vaccination gap.
CMS acknowledges that some providers and suppliers may be covered by both the ETS and the IFR. However, to the extent a provider or supplier is covered under the ETS and the IFR, the provider or supplier is expected to comply with the IFR. CMS explicitly states that the IFR takes priority above other federal vaccination requirements and preempts inconsistent State and local laws applied to Medicare- and Medicaid-certified providers and suppliers.
Covered Staff
Covered Staff is broadly defined and includes Covered Provider staff, regardless of clinical responsibility or patient contact, those who provide clinical and non-clinical services regardless of whether those duties are performed within a clinical- or non-clinical setting, employees, licensed practitioners, students, trainees, and volunteers, and individuals who provide care, treatment, or other services for the Covered Provider and/or its patients, under contract or other arrangement (e.g., independent contractors providing vendor or contracted clinical services). Recognizing the fluidity of rapidly changing healthcare staffing needs and workplace locations, CMS comments that even staff that primarily provide services remotely via telework and/or occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, may have to enter a health care facility or site of care for their job responsibilities. Therefore, CMS has determined that 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 are Covered Staff under the IFR.
The only explicit exclusions to the definition of Covered Staff are: (1) individuals who provide services 100% remotely, such as fully remote telehealth or payroll services, and; (2) individuals who infrequently provide ad hoc non-health care services (such as annual elevator inspection, and delivery and repair personnel). This small group of individuals are not subject to the IFR COVID-19 vaccination requirement.
CMS’ intent and the IFR impact is crystal clear – most Medicare- and Medicaid-certified providers and suppliers are required to ensure that their workforce is fully vaccinated for COVID-19.
Legal Exemption
While Covered Providers must comply with the IFR COVID-19 vaccination policies and procedures requirement, they are still subject to applicable Federal anti-discrimination laws and civil rights protections (e.g., the Americans with Disabilities Act, Title VII of the Civil Rights Act of 1964, the Pregnancy Discrimination Act). Accordingly, Covered Providers, in some instances, may be required to provide appropriate accommodations, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.
Enforcement
CMS will enforce IFR compliance through State surveyors (e.g., Departments of Health) and provide them with enforcement guidelines and training. For example, CMS states the guidelines will instruct surveyors on how to review the Covered Provider’s records of staff vaccinations and qualifying exemptions, how to conduct interviews of staff to verify their vaccination status, and how to review the sufficiency and completeness of the Covered Provider’s policies and procedures. CMS’s enforcement guidance to surveyors will also include steps on how non-compliant Covered Providers should be cited. Enforcement remedies will vary and depend on the level of noncompliance, and include civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement in the most extreme cases of severe or continued noncompliance.
Immediate Action Required to Ensure Timely Compliance
Due by December 4, 2021
Covered Staff must have the first dose of the primary vaccination series (i.e., Pfizer-BioNTech/Comirnaty or Moderna) or a single dose COVID-19 vaccine (i.e., Janssen/Johnson & Johnson)
Developed and implemented IFR policies and procedures to ensure Covered Staff are fully vaccinated for COVID-19
Legal exemption requested and/or granted by the Covered Provider
Due by January 4, 2022
All Covered Staff are fully vaccinated, except those who:
were granted legal exemption on or before January 4, 2022, or
could not be fully vaccinated by January 4th due to personal healthcare considerations
**Covered Staff who received the second/final dose of a primary vaccination series by January 4, 2022 are compliant with the vaccination requirement even if they have not yet completed the post second dose 14-day waiting period.
Compliance Considerations and How We Can Help
Policy and Procedure Development and Implementation - The IFR has specific policy and procedure requirements (e.g., process for ensuring the implementation of additional precautions to mitigate the transmission and spread of COVID-19 for Covered Staff who are not fully vaccinated for COVID-19, process for tracking and securely documenting information provided by those staff who have requested, and for whom the Covered Provider has granted an exemption from the COVID-19 vaccination requirement). We can draft and/or work with Covered Providers’ responsible persons to ensure IFR policies and procedures are legally sufficient, tailored to the specific operational needs of the Covered Provider, and provide training and education to the Covered Providers workforce.
We can draft and/or work with Covered Providers’ responsible persons to ensure IFR policies and procedures are legally sufficient, tailored to the specific operational needs of the Covered Provider, and provide training and education to the Covered Providers workforce.
Risk Assessment - Covered Providers will need to evaluate the sufficiency of their enterprise policies and procedures to ensure compliance and mitigate enforcement risk. While the IFR presents compliance risk in and of itself, downstream consequences of compliance impacts vendor contract obligations and requirements, HR and employee health operations, supply chain processes, vendor requirements and credentialing, etc. We can conduct formal risk assessments for Covered Providers to ensure that risk is sufficiently mitigated in accordance with their risk tolerance levels.
Enforcement Defense - In potential non-compliance and/or enforcement actions, we can facilitate a negotiated resolution on behalf of Covered Providers. Our experience includes successfully defending providers in state and federal healthcare enforcement matters, including those enforced by CMS, OIG, and other HHS agencies and offices, DOJ, and state attorney general offices.
What’s Next?
Based on the current policies of the Biden Administration, it would be reasonable to anticipate and/or plan for the IFR to continue through the end of 2022 or into 2023. Medicare interim final rules expire three years after issuance unless finalized, and CMS states in the IFR that it expects the public health considerations and circumstances that led to the implementation of this IFR to exist for some period of time after the expiration of the public health emergency. CMS expects to make a determination based on public comments, incidence, disease outcomes, and other factors regarding whether it will be necessary to conduct final rulemaking and make the IFR permanent. Regardless of whether the IFR becomes permanent, right now Covered Providers would be well served to consider the IFR an indefinite requirement and take action with this premise in mind to help facilitate a smooth and efficient implementation of the requirements and broad buy-in from their workforce.