The new requirement
Yesterday, November 4, 2021, in addition to the OSHA ETS applicable to most employers with 100 or more employees, the US Department of Health and Human Services (HHS) issued a “Provisional final rule with comment periodKnown as the “IFC,” requiring most hospitals and other Medicare and Medicaid certified providers and providers to develop and implement rules for mandatory COVID-19 vaccination by their employees. HHS estimates that approximately seventeen million employees will be covered by IFC. HHS also released Frequently Asked Questions to assist in the implementation of the IFC.
No test and mask option
Unlike OSHA ETS, CMS IFC does not not allow the substitution of a test and mask option. Compulsory vaccination is compulsory.
IFC takes the form of several new regulations, each applicable to one or more types of facilities. The regulations have a lot in common with the OSHA ETS, although there are some important distinctions. Generally, regulations impose an obligation to ensure that all staff are fully immunized, “regardless of clinical responsibilities or patient contact”. Employees may, however, be excluded if they practice telemedicine exclusively or work exclusively in a separate outside facility, without contact with patients or other staff. IFC does not apply directly to individual physician practices or other facilities not regulated by CMS.
In general, each of the different regulations of the mandate requires that a covered healthcare facility adopt policies and procedures that, at a minimum, include:
- A process to ensure that all non-exempt staff have received the first dose of the primary immunization series for a COVID-19 multidose vaccine or a single dose of the Johnson & Johnson vaccine ** before staff provide care, treatment or other services for the establishment and / or its patients by December 5, 2021;
- A process to ensure that all staff are fully vaccinated against COVID-19, with the exception of staff who have been granted exemptions or staff for whom COVID-19 vaccination should be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations by January 4, 2022;
- A process to ensure the implementation of additional precautions (as yet unspecified), intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated against COVID-19;
- A process for monitoring and securely documenting the COVID-19 vaccination status of employees;
- A process to safely track and document the COVID-19 vaccination status of any personnel who have been given booster doses as recommended by the CDC;
- A process by which staff can request an exemption from COVID-19 vaccination requirements based on applicable federal law (presumably on the basis of religion or disability);
- A process for securely tracking and documenting information provided by staff who have requested, and for which the facility has granted, exemption from immunization requirements;
- A process to ensure that all documents that confirm the recognized clinical risks for COVID-19 vaccines, and that support staff requests for medical exemptions from vaccination, have been signed and dated by a licensed practitioner who is not not the person requesting the exemption, and who is acting within their respective scope of practice;
- A process for ensuring the tracking and secure documentation of immunization status of personnel for whom COVID-19 vaccination should be temporarily delayed, as recommended by the CDC, due to clinical considerations, including, but not limited to, people with acute illness secondary to COVID-19 and people who have received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and
- Contingency plans (not specified) for staff who are not fully vaccinated against COVID-19.
Specific directives by type of installation
IFC amends existing federal regulations applicable to outpatient surgery centers; Hospices; Residential psychiatric treatment establishments; All Inclusive Care Programs for the Elderly (PACE); Hospitals (including acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals / institutions rehabilitation for inpatients); Long-term care facilities (LTC), including skilled nursing care facilities (SNF); Nursing facilities generally referred to as nursing homes; Intermediate care establishments for people with intellectual disabilities; Home Health Agencies; Complete outpatient rehabilitation facilities (CORF); Critical access hospitals; Clinics, rehabilitation agencies and public health agencies as providers of outpatient physiotherapy and speech therapy services; Community mental health centers (CMHC); Home infusion therapy providers; Rural health clinics / federally approved health centers and end-stage renal disease facilities. The actual regulations governing each installation differ in detail – sometimes important details – and should be read individually.
** Yesterday, the White House issued an announcement attempting to create consistency in vaccination timelines between the CMS rule, OSHA ETS and rules for government contractors saying that “employees reporting to the ETS, CMS or federal contractor rules will need to receive their final dose of vaccination – either their second dose of Pfizer or Moderna, or a single dose of Johnson & Johnson – by January 4, 2022. However, The White House announcement did not address the two-phase structure of the CMS rule.
It is not clear whether an employee’s receipt of a single dose Johnson & Johnson vaccine after December 5, 2021, but before January 4, 2022, would comply with the CMS rule. Although this employee will be fully vaccinated by January 4, 2022, he would not have met the phase 1 requirement under the CMS rule. Our team is closely monitoring any advice from CMS or the White House regarding this inconsistency, and our team is ready to advise clients on navigating their available options.