Update on CMS Enforcement of Vaccine Mandate

This article provides an update on the status of the CMS Vaccine Mandate, the litigation surrounding its implementation and CMS’s intent to begin enforcement on January 27, 2022.

As reported in our November 12, 2021, article (most recently updated on December 23), the Centers for Medicare and Medicaid Services (CMS) promulgated a health and safety regulation for Medicare-certified facilities on November 5, 2021 (the CMS Vaccine Mandate). Please review our previous article for a description of the mandate’s specific requirements, including the scope of facility “staff” (employees, volunteers, contractors and other individuals) to whom it applies. Since its promulgation, the CMS Vaccine Mandate has been the subject of multiple lawsuits by various states, resulting in a patchwork map of the country where the mandate is currently enforceable.

Update for States where the CMS Vaccine Mandate is Not Enjoined

On December 28, 2021, CMS announced through a Survey and Certification memorandum to State Agencies that it will begin enforcing the CMS Vaccine Mandate in states where the Vaccine Mandate is not enjoined. (An injunction is a court order preventing a party (here, CMS) from taking an action; therefore, in states where the CMS Vaccine Mandate is enjoined, the agency may not enforce the mandate.) The CMS Vaccine Mandate is not currently enjoined in California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington and Wisconsin. In other words, CMS may proceed with implementing the mandate in these 25 states (and in the District of Columbia and the territories), and on December 28, 2021, stated its intention to do so.

The new deadline for implementation of Phase 1, which requires facilities to have vaccine mandate policies and procedures in place and all staff (except those with exemptions) to have received their first dose of the vaccine, is January 27, 2022. Phase 2, which requires all staff to be fully vaccinated (but does not require booster shots), must be implemented by February 28, 2022.

In addition to the Survey and Certification memorandum, CMS issued guidance documents regarding the mandate for specific types of facilities as well as updated its External FAQ document.

The CMS Vaccine Mandate allows for religious and medical exemptions and accommodations based on existing federal law. Note that for religious exemptions, surveyors have been instructed in each of its guidance documents for Medicare-certified facilities not to assess the specific details of a religious exemption request or to assess the facility’s rationale for the acceptance or denial of the request. Rather, surveyors are instructed to review whether facilities have an effective process to allow for exemptions based on a staff request.

Also, while the CMS Vaccine Mandate allows for exemptions, the regulation still requires facilities to take additional precautions for staff who are not fully vaccinated to mitigate the spread of COVID-19. For example, CMS guidance to hospital surveyors says “[t]here are a variety of actions or job modifications a facility can implement to potentially reduce the risk of COVID-19 transmission including, but not limited to:

• Reassigning staff who have not completed their primary vaccination series to nonpatient care areas, to duties that can be performed remotely (i.e., telework), or to duties which limit exposure to those most at risk (e.g., assign to patients who are not immunocompromised, unvaccinated).
• Requiring staff who have not completed their primary vaccination series to follow additional, CDC-recommended precautions, such as adhering to universal source control and physical distancing measures in areas that are restricted from patient access (e.g., staff meeting rooms, kitchen), even if the facility or service site is located in a county with low to moderate community transmission.
• Requiring at least weekly testing for exempted staff and staff who have not completed their primary vaccination series, until the regulatory requirement is met, regardless of whether the facility or service site is located in a county with low to moderate community transmission, in addition to following CDC recommendations for testing unvaccinated in facilities located in counties with substantial to high community transmission.
• Requiring staff who have not completed their primary vaccination series to use a NIOSH-approved N95 or equivalent or higher-level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients.

(Emphasis added.)

CMS will enforce the Vaccine Mandate through its survey and certification process, which the agency notes that for skilled nursing facilities, home health agencies and hospice providers, may include enforcement remedies such as civil monetary penalties and denial of payment for new admissions. (Termination of Medicare and Medicaid participation is a potential enforcement remedy for all affected facilities.) CMS has stated that facility staff vaccination rates under 100 percent constitute noncompliance under the rule. While the tone of its guidance is serious, CMS states that its goal is to bring health care facilities into compliance and give them an opportunity to correct deficiencies.

The Survey and Certification memorandum announcing enforcement was released on December 28, 2021. CMS has instructed surveyors to focus on “vaccination status and [facility] policies to address vaccination for staff that regularly work in the [facility] (e.g., weekly), using a phased in approach.” This approach uses 30, 60, and 90-day benchmarks for compliance. Within 30 days of the December 28, 2021, memorandum’s issuance, facilities are expected to have policies and procedures in place to ensure that all staff are vaccinated and 100 percent of staff must have received their first dose of the COVID-19 vaccine, have a pending request for an exemption, have been granted an exemption or have been identified as having a temporary delay based on CDC guidance. Within 60 days, 100 percent of staff are to be fully vaccinated, have been granted an exemption or have been identified as having a temporary delay if recommended by CDC guidance. Within 90 days of the issuance of the memorandum, facilities failing to maintain compliance may be subject to enforcement action. Surveyors for other types of facilities have been provided with the same phase framework.

We encourage facilities in states where the CMS Vaccine Mandate is not enjoined to review the Survey and Certification memorandum, updated External FAQ document and applicable facility specific guidance documents and begin steps to comply with the CMS Vaccine Mandate as soon as possible so as to meet the Phase 1 deadline of January 27, 2022.

Update for States where the CMS Vaccine Mandate is Enjoined

The CMS Vaccine Mandate is currently enjoined 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, Texas, West Virginia and Wyoming.

In the absence of a CMS Vaccine Mandate, facilities may need to comply with the November OSHA ETS and any state law regarding vaccination mandates. The November OSHA ETS requires vaccination or testing and masking for employers with 100 or more employees. The November OSHA ETS has an exception—that is, an employer need not require vaccines or testing and masking—if the employer follows all of the multi-layered safety protections of OSHA’s June Healthcare ETS (a different infection control safety standard that does not require vaccination or testing). However, on December 27, 2021, OSHA made a statement announcing that it is officially withdrawing its June Healthcare ETS, effective immediately. This means that the November OSHA ETS will now apply to all employers with 100 or more employees, including those employers who were previously relying on the exception in the November ETS for “settings where any employee provides healthcare services or healthcare support services when subject to the requirements of § 1910.502 [the June Healthcare ETS].”

Enforcement of the November OSHA ETS will begin on January 10, 2022. For more information regarding the November 2021 OSHA ETS, please reference the article released by our colleagues in the Employment & Labor Group. Note that while the November OSHA ETS is currently enforceable—i.e., it is not enjoined—a lawsuit challenging it will be heard by the U.S. Supreme Court on January 7, 2022.

Update on U.S. Supreme Court Treatment of CMS Vaccine Mandate

On January 7, 2022, the U.S. Supreme Court will hear oral arguments with respect to the CMS Vaccine Mandate and to an appeal of a recent decision by the Sixth Circuit Court of Appeals lifting the nationwide injunction against enforcement of the November 2021 OSHA ETS.

Fredrikson is monitoring these cases and will continue to inform you of major developments.