Last week the Center for Medicare and Medicaid Services (CMS) issued new omnibus regulations relating to facility-mandated COVID-19 vaccine programs. The regulation covers a wide array of healthcare providers including hospitals, ambulatory surgery centers, long-term care, hospice, and home health, and also encourages other healthcare providers such as individual doctor’s offices, who may not be covered, to comply with the new OSHA regulations which were also issued last week.   

Potential Penalties

These regulations provide fairly aggressive penalties for noncompliance including civil and monetary penalties, denial of payment, and potential termination from the Medicare and Medicaid program. At this time, the new law, Iowa Code 94.2, does not carry any specific penalties or mechanisms for compliance.  

These CMS requirements will be part of any state survey and CMS has indicated it will work directly with state agencies to review compliance matters. The standards will also require accrediting organizations such as the Joint Commission to update their survey process to take these issues into account.

Vaccine Programs

The CMS omnibus regulations require that covered healthcare facilities establish a vaccine program for all staff “regardless of clinical responsibility or patient contact.”  The only potential staff exempted from this would be those who never interact with anyone else at the facility. One example might be a payroll processor who works four states away and never comes into contact with anyone at the facility. The regulation is intended to be broadly enforced and employers need to have clear evidence that a person is fully remote with no contact. 

CMS also indicates that for Phase 1 of enforcement, staff must be vaccinated within 30 days, and for Phase 2, within 60 days unless granted an approved exemption. Fully vaccinated is defined as 14 days after a final dose of any COVID vaccine. At this time, fully vaccinated does not require booster shots, however, this is an area that CMS will continue to evaluate.

No Testing Requirement

Unlike the OSHA regulations also issued on November 5, 2021, the CMS guidelines do not include a testing alternative for unvaccinated staff. Employers are required to establish clear policies to mitigate COVID-19 which should focus on mitigation measures for those who are unvaccinated. This new omnibus regulation does not change the pre-existing emergency regulation from September 2020, which established requirements for nursing home testing in certain circumstances. These two regulations will operate together rather than separately. 

Exemptions

While no new data reporting requirements are required, facilities should make sure they are collecting vaccine cards or other vaccine information for all employees and also must maintain records of any exemption request. The CMS statements on what is an exemption are very narrow. CMS states that it “believes that exemptions could be appropriate in certain limited circumstances, but 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 request an exemption solely to evade vaccination.” This section appears to come into direct conflict with Iowa’s new statute regarding how exemption requests should be processed or supported, particularly medical exemptions where a provider statement is required. 

Also note that while vaccination may be temporarily delayed, as recommended by the CDC, for someone who has recently had COVID-19 antibody tests are not accepted as a valid exemption, with CMS stating specifically “staff who have previously had COVID-19 are not exempt from these vaccination requirements.” 

Compare and Contrast with Iowa Law

Before assessing the differences between the CMS Omnibus Regulation and Iowa’s 94.02, facilities should be aware of the direct statement from CMS in its Q&A, which specifically addresses the issue of state law and vaccine mandates, “… this regulation preempts any state law to the contrary…”

It is CMS’s clear intention to preempt any state law which would impede the vaccine process. If CMS has a more stringent standard than state law, then that is what they will apply.

Iowa Code § 94.2 states that a vaccine exemption should be granted by an employer for an employee if the employee submits (1) a statement that receiving the vaccine would be injurious to the health and wellbeing of the employee or an individual residing with the employee; or (2) a statement that receiving the vaccine would conflict with the tenets and practices of a religion of which the employee is an adherent or member. 

This section does not appear to meet the requirements of the CMS regulation and would not be the standard practice under the ADA/ADAAA or Title VII. From a practical perspective, employers rarely, if ever, would have a workplace accommodation policy that did not require supporting medical documentation. Employees with work restrictions are typically required to provide statements from their treating provider to support any requests for modification or accommodation in the workplace. This is true for everything from a lift restriction to a request for a support animal.

The CMS regulations specifically state that for a medical exemption there must be a statement from a treating provider acting within their scope of practice and such a statement must be which vaccines are clinically contradicted and their recognized clinical reason.

Recognized clinical reasons are those outlined by the CDC or similar agency.  Further, the EEOC pursuant to Title VII allows inquiry to determine whether or not something is truly a religiously held belief particularly if there is concern that the statement may be untrue. See our article from last week, EEOC Update - What You Should Know About COVID-19 Vaccinations.

Additionally, a portion of the state statute would allow an individual to assert that the wellbeing of someone they live with would be affected by that employee getting the vaccine.  This is a discussion that has occurred primarily on social media where people have expressed concerns that obtaining the vaccine could somehow render that person contagious. As the CDC has indicated on multiple occasions, the existing vaccines used within the United States do not use a live virus, therefore, do not cause viral shedding.  Because this section is not in compliance with CDC and other scientific guidelines it is unlikely to meet the CMS requirements for an exemption.

While religion and the processing of that type of request is similar to Iowa law, the CDC is clear that it will be looking for suspect requests and will reflag certain items.

The Big Picture

Perhaps most importantly, facilities should take a deep breath. Much of this documentation has already been gathered as healthcare providers are already required to implement policies, programs, and practices for vaccines. And many things already exist due to the significant amount of regulation healthcare has faced throughout the COVID-19 pandemic.

For example, healthcare employers can utilize many of the processes that are already in place, such as for workplace restriction requests or the exemption process hospitals may use for mandated influenza vaccines.

While fine-tuning may be required, most facilities do not need to start entirely from scratch, and because the testing option is not required under the CMS guidelines, they do not need to implement new and extensive testing programs with significant documentation and paperwork requirements. 

The big picture for healthcare providers: 

• Vaccine programs should be clearly defined and consistently enforced following the standards set out by the EEOC.
• Employers need to document the vaccine status of all employees and confidentially maintain these records in the employee health file.
• Boosters and delayed vaccines need to be tracked.

Related Resources

• CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule - Centers for Medicare & Medicaid
• Vaccinations Required for Staff Working in Medicare-Medicaid Facilities - Holley Thames Lutz, Susan Banks, Mary Ellen Palowitch
• OSHA Release Long-Awaited Vaccination Rule: 3 Key Takeaways - Julie Vanneman, Chad Wissinger, Sandra McCandless, Peter Stockburger
• Health Law Quick Take: CMS Volunteer Vaccine Guidelines - Jo Ellen Whitney