CMS Issues Draft Interim Final Rule Regarding Mandatory COVID Vaccines
November 4, 2021
On November 4, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued a draft of its long-awaited interim final rule (“IFR”) regarding mandatory Covid-19 vaccinations, which is expected to be formally published in the Federal Register on November 5, 2021. CMS establishes rules for participating in Medicare and Medicaid programs. The IFR applies to certain healthcare employers that receive Medicare and Medicaid funding and reimbursement, such as hospitals, residential treatment facilities, long term care facilities, rural health clinics, and federally qualified health centers.
Under the IFR, Medicare and Medicaid providers are required to ensure that all staff are fully vaccinated for Covid-19 by receiving a “complete primary vaccination series” within 60 days of publication of the rule. Assuming the IFR is published in the Federal Register on November 5, 2021, covered employers will have until January 4, 2022, to ensure that their staffs are fully vaccinated.
Notably, unlike the Emergency Temporary Standard that is also expected to be published tomorrow, the IFR does not include an explicit testing alternative. In other words, healthcare employers will be required to impose a straight up vaccine mandate. The IFR makes clear, however, that employers are still expected to provide medical and religious exemptions, assuming employees qualify for those accommodations under the Americans with Disabilities Act and Title VII of the Civil Rights Act of 1964.
The CMS rule requires employers to track and document the vaccination status of each employee, as well as any requests for vaccine exemptions and documented outcomes of each exemption request. Although the CMS rules does not require employers to mandate vaccine boosters, it does require employers to track and document the vaccination status of employees who have obtained booster doses. This tracking requirement suggests that CMS may require employers to mandate boosters at a future date.
The coverage of the CMS rule is broad; it’s not limited to just employees. The vaccine mandate will also apply to licensed practitioners, students, trainees, volunteers, and other individuals who provide care, treatment or other services for patients, regardless of whether these individuals are working in a clinical setting. Only those employees who work 100 percent remotely, and have no interaction with patients and staff, are excluded from the vaccine mandate. Additionally, the vaccine mandate does not apply to vendors that provide “ad hoc non-health care services.” The example cited by CMS includes elevator inspections. Likewise, covered employers are not required to ensure Covid-19 vaccinations for all persons who enter the facility.
Interestingly, CMS has noted that its rule “preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this [rule].” This issue has been flagged by legal commentators for several months in light of various state and local efforts to restrict employers’ ability to mandate Covid-19 vaccinations. For example, the West Virginia Legislature recently adopted HB 335, which creates a separate class of medical and religious exemptions for employees that are required to receive a Covid-19 vaccination as a condition of continued employment. Assuming an employee qualifies for one of these exemptions, then the employer is prohibited from discharging that employee or altering other terms and conditions of employment. This contrasts with current federal law which allows employers to reassign employees to different jobs (with different rates of pay) or place employees on leaves of absences if their requests for accommodation pose an undue burden or otherwise prevent the employee from performing the essential functions of their job. Given the current political climate associated with Covid-19 vaccinations, we expect several legal challenges to this new federal mandate.