Health Care Client Alert – The New Centers for Medicare and Medicaid Services (CMS) Rule
The New Requirement
Yesterday, November 4, 2021, in addition to the OSHA ETS applicable to most employers with 100 or more employees, the U.S. Department of Health and Human Services (HHS) issued an “Interim Final Rule with comment period,” known as an “IFC,” requiring most hospitals and other Medicare- and Medicaid-certified providers and suppliers to develop and implement rules for mandatory vaccination against COVID-19 by their employees. HHS estimates about seventeen million employees will be covered by the IFC. HHS also released Frequently Asked Questions to aid implementation of the IFC.
No Test and Mask Option
Unlike the OSHA ETS, the CMS IFC does not allow substituting a test-and-mask option. Mandatory vaccination is required.
The IFC takes the form of multiple new regulations, each applicable to one or more types of facilities. The regulations have much in common with the OSHA ETS, although there are important distinctions. Generally, the regulations impose a requirement to ensure that all staff are fully vaccinated, “regardless of clinical responsibilities or patient contact.” Employees may, however, be excluded if they exclusively practice telemedicine, or exclusively work in a separate, outside facility with no contact with patients or other staff. The IFC does not apply directly to individual physicians’ offices or other facilities not regulated by CMS.
Stated generally, each of the varying regulations within the mandate requires that a covered healthcare facility must adopt policies and procedures that, at a minimum, include:
- A process for ensuring all non-exempt staff have received the first dose of the primary vaccination series for a multi-dose OVID-19 vaccine or a single dose of the Johnson & Johnson vaccine** prior to staff providing any care, treatment, or other services for the facility and/or its patients by December 5, 2021;
- A process for ensuring that all staff are fully vaccinated for COVID-19, except for those staff who have been granted exemptions, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations by January 4, 2022;
- A process for ensuring the implementation of (yet-unspecified) additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;
- A process for tracking and securely documenting employee COVID-19 vaccination status;
- A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;
- A process by which staff may request an exemption from the COVID-19 vaccination requirements based on an applicable Federal law (presumably on the basis of religion or disability);
- A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the vaccination requirements;
- A process for ensuring that all documentation which confirms recognized clinical risks to COVID-19 vaccines, and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner who is not the individual requesting the exemption, and who is acting within his or her respective scope of practice;
- A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and
- Contingency plans (not specified) for staff who are not fully vaccinated for COVID-19.
Specific Guidance By Type of Facility
The IFC amends the existing federal regulations applicable to Ambulatory Surgical Centers; Hospices; Psychiatric residential treatment facilities; Programs of All-Inclusive Care 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/inpatient rehabilitation facilities); Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs); Nursing Facilities generally referred to as nursing homes; Intermediate Care Facilities for Individuals with Intellectual Disabilities; Home Health Agencies; Comprehensive Outpatient Rehabilitation Facilities (CORFs); Critical Access Hospitals; Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services; Community Mental Health Centers (CMHCs); Home Infusion Therapy suppliers; Rural Health Clinics/Federally Qualified Health Centers, and End-Stage Renal Disease Facilities. The actual regulations governing each facility differ in detail – sometimes important detail – and should be consulted individually.
For Further Assistance:
Our Labor and Employment Law Section has been working with our clients daily on COVID-19 issues, including compliance with law and regulation and strategies for mitigation, since March 2020. We have developed model policies, forms, and procedures that can be adapted for the needs of our individual clients. Please feel free to contact us for prompt assistance at any time.
**Yesterday, the White House released an announcement attempting to create consistency in the vaccination deadlines between the CMS Rule, OSHA ETS, and rules for government contractors by saying that “employees falling under the ETS, CMS, or federal contractor rules will need to have their final vaccination dose – 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 CMS Rule’s two phase structure.
It is unclear 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 would be fully vaccinated by January 4, 2022, they would not have met the Phase 1 requirement under the CMS Rule. Our team is closely monitoring any notice from CMS or the White House regarding this inconsistency, and our team is ready to advise clients on navigating their available options.
The contents of this publication are intended for general information only and should not be construed as legal advice or a legal opinion on specific facts and circumstances. Copyright 2023.