After tumultuous weeks in litigation and appeals, the United States Supreme Court unblocked the CMS Vaccine Mandate on January 13, 2022. The court battles are not over, but the CMS Vaccine Mandate will go into effect while they rage on. Buckle up, there’s a lot to talk about.
A Brief History
On November 5, 2021, CMS issued a mandate requiring all CMS-regulated health entities to mandate vaccines for all personnel. Shortly afterwards, several lawsuits were filed seeking injunctions and to overturn the mandate. CMS announced on December 2, 2021, that it would not enforce the mandate pending the results in the lawsuits.
However, on December 28, 2022, CMS issued new compliance dates for about half of the states, given that the injunction had been overturned in those states. CMS required hospitals (and other regulated entities) in those states to mandate all staff (broadly defined as discussed in our prior alerts) to be vaccinated with the first dose no later than January 27, 2022, and with the second dose as applicable by February 28, 2022. CMS stated in that December 28, 2022 memorandum that it would not regulate the other half of the states that were still enjoined.
The Supreme Court heard arguments for almost all injunctions on the CMS mandate (in addition to the similar mandate issued by OSHA for large employers) lawsuits on January 7, 2022. On January 13, 2022, in a 5-4 decision, the Supreme Court overruled previous injunctions that had blocked the mandate. The Supreme Court had not addressed the injunction issued in Texas, so that is an outlier, but the mandate is now enforceable in all other states, pending appellate review on the merits. Given that CMS's December 28, 2022 guidance explicitly stated that it would not enforce the mandate in the states where it was blocked at the time, it is unclear if those states are subject to the same dates… But we think everyone should assume that the January and February compliance dates apply everywhere (except maybe Texas).
What Does This Mean for Hospitals and CAHs Specifically?
The guidance for hospitals and critical access hospitals (referred to herein collectively as "hospitals") is available at https://www.cms.gov/files/document/qso-22-07-all-attachment-d-hospital.pdf and QSO-22-07 ALL Critical Access Hospitals (CAH) Attachment (cms.gov) respectively. CMS is regulating the vaccine requirement as a Condition of Participation (CoP) in Medicare. The mandate is implemented as a part of the Infection Prevention and Control CoP. Critical Access Hospitals (CAHs) Tag C-1260, Hospitals Tag A-0792. The requirements for both CAHs and Hospitals are the same.
CMS requires that 100% of hospital staff receive their first dose of a two-dose vaccine series or the full dose of a single-dose vaccine by January 27, 2022. Hospitals must also have policies and procedures in place to ensure that these dates are met. The only staff who are not subject to the mandate are those who are entirely remote (explained further below) or those who have received an approved medical or religious exemption or an approved delay of vaccination consistent with CDC guidelines. Safeguards are required for any exempted or delayed staff.
An Initial Reprieve for Hospitals that are Mostly Compliant.
- 60 Day Reprieve Prior To February 28: For surveys conducted between January 27 and February 28: If a hospital is at least 80% compliant (meaning at least 80% of staff have received one dose of the vaccine, or have an exemption or approved delay) AND there is a plan to achieve full compliance, the hospital will be issued a notice of non-compliance and be given 60 days from that notice to come into compliance.
- 30 Day Reprieve Between February 28, 2022 and March 28, 2022: For surveys conducted between February 28 and March 28, 2022: If a hospital is at least 90% compliant (meaning at least 90% of staff have had at least one dose, or have an exemption or approved delay) AND there is a plan to achieve full compliance, the facility will be issued a notice of non-compliance and be given 30 days from that notice to come into compliance.
- No Reprieve After March 28: For any survey conducted on or after March 28, 2022, facilities must be in full, 100% compliance.
Requirements for the Policies and Procedures:
Under the CoP, the hospital must develop and implement policies and procedures to ensure all staff are fully vaccinated against COVID-19. Staff are considered fully vaccinated if it has been two weeks or more since they had a single-dose vaccine or both doses of a two-dose vaccine—however the hospital is considered compliant as soon as the vaccine series are completed, not two weeks after.
The policy required under the CoP must include a process for:
- Ensuring all staff (other than pending or granted requests for exemption or delay) have received their first dose by January 27, 2022, and second dose, if applicable, by February 28, 2022.
- Ensuring the implementation of precautions for staff who are not fully vaccinated. Safeguards recommended by the CDC include the following - although these are not explicitly required nor are they the only possible safeguards:
- Reassigning staff who have not completed their primary vaccination series to non-patient care areas or duties that can be performed remotely (e.g. telework) or to patients who are not immunocompromised.
- Requiring such staff to adhere to CDC measures such as masking and physical distancing measures.
- Requiring at least weekly testing until the regulatory requirement is met.
- Requiring a heavy-duty mask and face shield.
- Tracking and securely documenting vaccination status, including:
- Vaccine received
- Dates of each dose received (or scheduled for multi-dose vaccine series).
- Any exemptions granted, including type of exemption and supporting documentation.
- Approved delays, along with date of safe resumption of the vaccination series.
- Any boosters that are received by staff, including the date and type of vaccine.
- A process for requesting and tracking medical or religious exemptions or delays.
- Documentation of clinical contraindications and support of medical exemption requests signed and dated by a licensed practitioner and containing:
- All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications.
- A statement by the authenticating practitioner recommending that the staff member is exempted based on those reasons.
- "Contingency plans" (i.e. consequences) for staff who refuse to get vaccinated but do not qualify for an exemption.
More Detail – The Big Sticking Points
Who At Your Hospital Must Be Vaccinated?
Broadly Defined: Hospital staff includes any staff regardless of clinical responsibility or patient contact. Hospital employees, licensed practitioners, students, trainees, and volunteers, and vendors (or other contractors even if not in writing) are all potentially included.
Remote Workers Excluded: The rule does not apply to staff who exclusively provide telehealth outside of the hospital setting and staff who provide support services for the hospital performed outside of the hospital setting. For both of these categories, the staff must have no other contact with patients or other staff. Hospitals must track the staff members who are not covered by the mandate.
How to Handle Exemptions:
The process for requesting an exemption must be established in the written policy, and each step in the process must be tracked including whether or not the exemption was granted. If the hospital is relying on a contractor who processed the exemptions, the hospital must have the appropriate documentation in hand - until then the person is considered unvaccinated and must follow the safeguards.
Medical Exemptions – When evaluating a request for a medical exemption, hospitals should refer to CDC recognized clinical contraindications. For example, a history of severe allergic reaction (e.g., anaphylaxis) after a previous COVID-19 vaccine dose would qualify as a clinical contraindication. Any request for a medical exemption must specify the particular contraindicated vaccine and the recognized clinical reasons for contraindication and must be signed and dated by a licensed practitioner acting within the scope of practice.
Religious Exemptions – When evaluating a request for a religious exemption, hospitals should refer to the EEOC compliance manual on religious discrimination. Importantly, surveyors will not evaluate the details of the request for a religious exemption nor the rationale for the hospital’s acceptance or denial of the request. The rule only requires that the hospital has an effective process for staff to request a religious exemption for a sincerely held religious belief.
How To Handle Staff Who Refuse Vaccination:
Hospitals must have "contingency plans" for staff that are not fully vaccinated including what will happen when staff members refuse vaccination but do not qualify for an exemption. The plan should also specify the safeguards for those who are not due to an exemption or a temporary delay in vaccination. While CMS does not outright state that staff who refuse vaccination but do not qualify for an exemption must be fired, continuing to employ such staff would constitute a violation of the CoP requirements. CMS does give some room for the transition period, such as suggesting that the contingency plan include a notice that unless the refusing staff member is vaccinated by a certain date, the hospital will bring in temporary or permanent replacement staff as soon as they can be located. In the interim, hospitals should do everything possible to lower the risk e.g. reassigning the staff member to non-clinical care or to patients at low risk.
Deficiencies and Surveys:
CMS is very specific as to what level of deficiency is appropriate for various levels of noncompliance with the mandate. Essentially, the higher the percentage of unvaccinated (and non-exempt) staff, the higher the level of deficiency. Not having a fully developed or implemented policy can also get hospitals in trouble. Here are the levels and the survey findings that would merit them:
Surveyed hospitals can be put in immediate jeopardy status if 40% or more of staff remain unvaccinated by the required dates, creating a likelihood of serious harm. Similarly, the hospital can be put in immediate jeopardy if it (1) does not meet the 100% staff vaccination rate standard by the required dates (2) the surveyor observes non-compliant infection control practices from staff (such as a failure to properly don PPE) and (3) one or more of the required components of the policies and procedures was not developed or implemented.
Condition Level Deficiency
Hospitals may be cited for a condition level deficiency if they did not meet the 100% staff vaccination rate standard and one or more components of the policies and procedures were not implemented. A condition level deficiency may also be issued if 21-39% of staff remain unvaccinated creating a likelihood of serious harm.
Standard Level Deficiency
A standard level deficiency may be imposed if the hospital meets the 100% staff requirement and all new staff (hired in the last 60 days) have received at least one dose but one or more of the components of the policies and procedures requirement was not developed and implemented. Similarly, as outlined above, if the hospital does not meet the 100% vaccination standard but are making good faith efforts towards compliance, then a standard level deficiency may be given.
Quarles & Brady will continue to monitor developments with respect to the CMS Rule and the latest COVID-related recommendations from the CDC.