Health Law Alert

  
 

CMS Issues Interim Final Rule Requiring Covid-19 Vaccinations For Medicare And Medicaid Provider Staff

On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS) will release an interim final rule requiring Medicare and Medicaid-certified health care providers and suppliers to ensure that their staff are fully vaccinated for COVID-19 no later than January 4, 2022. The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Rule (“Rule”) applies to eligible staff regardless of clinical responsibility or patient contact, including all current and new staff who provide any care, treatment, or other services for the provider and/or its patients. This also includes licensed practitioners, students, trainees, and volunteers, as well as individuals who provide care, treatment, or other services for the provider and/or its patients under contract or other arrangements.

Additionally, these requirements are not limited to performance of duties within a formal clinical setting; they also apply to health care staff who provide services outside of facilities, including home health, hospice, etc. To ensure maximum patient protection, the Rule applies to all staff who interact with other staff, patients, residents, clients, or PACE program participants in any location. However, providers do not have to ensure vaccination of individuals who may infrequently enter a site of care for specific limited purposes and for a limited amount of time and who do not provide services by contract or under arrangement, such as delivery and repair personnel.

The Rule requires providers to establish a process or policy to fulfill the staff vaccination requirements over two phases. For Phase 1, by December 5, 2021, all staff must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine prior to providing any care, treatment, or other services. For Phase 2, by January 4, 2022, all staff must complete the primary vaccination series, except for those staff who have been granted exemptions from vaccination under existing federal law or for whom vaccination must be temporarily delayed as recommended by the Centers for Disease Control (CDC).

For purposes of this Rule, CMS considers staff to be fully vaccinated if it has been two (2) weeks or more since they completed a primary vaccination series for COVID-19. Staff who have completed the primary series for the vaccine received by Phase 2 are considered to have met these requirements even if they have not yet completed the 14-day waiting period required for full vaccination. 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).

Of course, the new Rule requires employers to continue complying with applicable federal anti-discrimination laws and civil rights protections, including the Americans with Disabilities Act (ADA); Section 504 of the Rehabilitation Act (RA); Title VII of the Civil Rights Act of 1964; the Pregnancy Discrimination Act; and the Genetic Information Nondiscrimination Act. Accordingly, employers may be required to provide appropriate accommodations, to the extent required by federal law, for employees who request and receive exemption from vaccination because of a disability, medical condition, or sincerely held religious belief, practice, or observance.

CMS encourages providers to consider on-site vaccination programs, which may significantly reduce barriers that staff can face in getting vaccinated, including transportation barriers, a need to take time off of work, and scheduling.

To ensure compliance with the Rule, CMS is requiring providers to track and securely document the vaccination status of each staff member, including those for whom there is a temporary delay in vaccination. Exemption requests, supporting documentation, and outcomes must also be documented and maintained. Vaccine documentation must be kept confidential and stored separately from an employer’s personnel files. CMS suggests that acceptable forms of documentation may include: CDC COVID-19 vaccination record card (or a legible photo of the card), or documentation of vaccination from a health care provider, or electronic health record, including state records. According to the Rule, providers have the flexibility to use the appropriate tracking tools of their choice. The CDC provides a staff vaccination tracking tool that is available on the NHSN website (https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html) which providers can use to track COVID-19 vaccinations for staff members.

In enforcing this Rule, CMS will work directly with State Survey Agencies to conduct onsite compliance reviews during standard recertification surveys and complaint surveys. Surveyors will review COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the preceding four (4) weeks, and a list of all staff and their vaccination status. This information, in addition to interviews and observations, will be used to determine the compliance of the provider with these requirements. There are a variety of enforcement remedies that may be used by CMS including civil monetary penalties, denial of payment, and even termination, as applicable. However, CMS continues to stress that its goal is to bring providers into compliance and not resort to termination, if possible.

Finally, this Rule was created to be complementary to the OSHA emergency temporary standard which applies to employers with 100 or more employees. Additionally, this Rule preempts any state law to the contrary. If a Medicare or Medicaid certified provider or supplier falls under the requirements of this Rule, it must adhere to these requirements first, regardless of any conflicting state law. All providers and suppliers that are certified under the Medicare and Medicaid programs are regulated by the CMS standards known as Conditions of Participation, Conditions for Coverage, and Requirements for Participation, must abide by the requirements established by this Rule.

If you have questions about how this Rule, the OSHA Covid-19 Employer Emergency Temporary Standard, or any other vaccination requirements may affect your business, please contact us for more help.

UPDATE: On November 29, 2021, the U.S. District Court for the Eastern District of Missouri issued a preliminary injunction halting enforcement of the CMS Rule in ten (10) states, including Arkansas. On November 30, 2021, the U.S. District Court for the Western District of Louisiana issued a nationwide injunction to the Rule for all remaining states. Enforcement and implementation of the Rule are effectively halted until further action of the Court(s). On December 2, 2021, CMS suspended enforcement for as long as the injunctions remain in effect. Healthcare employers covered by the CMS Rule have been granted a temporary reprieve. However, we do not know how long this reprieve may be. Therefore, it is important that employers take a cautious approach and continue preparation for compliance with the mandate should it survive judicial review, including establishing a written policy and creating a plan for potential implementation. Employers should also consider how to explain the pending litigation and current delay in implementation. Finally, employers should ensure they are in compliance with state and local laws. For instance, beginning, Arkansas employers must provide a testing exemption alternative in compliance with Arkansas Act 1115.

Update (1/26/2022): The temporary injunction against this Rule has been lifted. Health care providers in 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 must ensure staff have received their first dose in a multi-dose vaccine series by February 14, 2022, and must ensure all staff have received all necessary shots in their applicable vaccine series (or an exemption) in compliance with the Rule by March 15, 2022. For states not impacted by the Supreme Court decision, the previously announced compliance dates remain in effect. Importantly, health care providers in Texas must be in compliance with the Rule with new corresponding effective dates of February 19 and March 21.