On November 5, 2021, the Centers for Medicare & Medicaid Services (“CMS”) published an interim final rule (the “IFR” or “Rule”) that changes Medicare regulations to require vaccination of certain health care workers against SARS-CoV-2. The Rule, titled “Omnibus COVID-19 Health Care Staff Vaccination Rule” requires compliance by covered entities in two stages based on the series of vaccinations.
- Phase 1 of the Rule will take effect December 6, 2021.
- Phase 2 of the Rule will take effect January 4, 2022.
- The Rule will be open for comment. Comments are due on January 4, 2022, by 5 p.m.
According to its terms, the Rule is fully severable and if any portion of the Rule is held invalid by a court, the remainder of the Rule will remain in effect in its entirety.
Sections 1102 and 1807 of the Social Security Act (42 USC 1302 and 42 USC 1395hh, respectively). The Rule is issued as a mandatory requirement of participation/enrollment in the Medicare and Medicaid programs.
Overview of Regulation
CMS has implemented health and safety standards for 21 types of providers and suppliers. These requirements are known variously as the Conditions of Participation, Conditions for Coverage, or Requirements for Participation and are general obligations for enrollment in Medicare. The Rule amends these safety standards to create a SARS-CoV-2 vaccination obligation for employees and staff, with relted tracking and documentation requirements, and an obligation to follow nationally recognized infection prevention and control guidelines to mitigate the transmission and spread of SARS-CoV-2. Compliance is enforced by state survey agencies.
The Rule applies to the following list of Medicare providers and suppliers (listed with the relevant section of Title 42 of the CFR):
- Ambulatory Surgical Centers (ASCs) (§ 416.51)
- Hospices (§ 418.60)
- Psychiatric residential treatment facilities (PRTFs) (§ 441.151)
- Programs of All-Inclusive Care for the Elderly (PACE) (§ 460.74)
- Hospitals (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) (§ 482.42)
- Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes (§ 483.80)
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) (§ 483.430)
- Home Health Agencies (HHAs) (§ 484.70)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs) (§§ 485.58 and 485.70)
- Critical Access Hospitals (CAHs) (§ 485.640)
- Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services (§ 485.725)
- Community Mental Health Centers (CMHCs) (§ 485.904
- Home Infusion Therapy (HIT) suppliers (§ 486.525)
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) (§ 491.8)
- End-Stage Renal Disease (ESRD) Facilities (§ 494.30)
Entities that are not listed above are not directly subject to the Rule, and this includes some notable exceptions. For example, physicians and physician offices are not subject to the Rule directly because they do not have CMS Conditions for Coverage (physicians are classified as “suppliers” under Medicare law) and are not surveyed by state survey agencies. That said, a physician who has staff privileges at a hospital would be subject to the Rule by virtue of its application to the hospital. DMEPOS suppliers, such as pharmacies, are another example of a Medicare enrollment that is not directly subject to the Rule. Organ Procurement Organizations and Portable X-Ray suppliers are a further example.
With regard to Long Term Care facilities, the rule specifically removes the ability of staff to refuse vaccination, a provision that was included in earlier rules applicable to LTC facilities.
Of note, however, affected providers and suppliers can approve exemptions subject to rules addressing evaluating and documenting those requests.
Organizations that are not subject to the Rule may still be subject to the OSHA Emergency Temporary Standard that requires vaccination or regular testing and masking for all corporations with 100 or more employees. (See here for more information on the OHSA Emergency Temporary Standard for Workplace Vaccination Policies.)
The CMS Rule applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. The requirement includes all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients. This includes facility employees, licensed practitioners, students, trainees, and volunteers. Additionally, this also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements.
However, employees who work in a 100% remote setting through telework are not covered by the Rule. The Rule contemplates certain other fact-specific circumstances under which ad hoc service providers, such as annual elevator inspection personnel, may not be covered by the Rule.
Phase 1: As of December 6, 2021, all covered individuals must have either completed the initial dose of a primary series of vaccination or have applied for an exemption for religious or health reasons.
Phase 2: As of January 4, 2022, all covered individuals must have either completed the primary series of vaccination or have been approved for an exemption for religious or health reasons. The employee need not have passed through the 2-week post-vaccination period that generally defines complete vaccination, they need only have received their complete series of vaccines.
The rule requires the immunized staff to have received EITHER the FDA authorized vaccines OR the World Health Organization list of approved vaccines.
There is no option for affected providers and suppliers to choose to test their employees regularly instead of implementing the vaccine mandate across the company. However, should an employee obtain a religious or medical exemption from the mandate, the provider or supplier must implement procedures to minimize the spread of COVID-19 in the workplace (i.e., regular testing and masking).
The requirements will be monitored by state survey agencies that will survey the vaccination policies and procedures, as well as the status of all employees from the 4 weeks prior to the survey, for compliance. We assume that providers and suppliers will receive deficiencies if they do not meet this requirement. Under the current survey and certification system, a facility will have an opportunity to submit a plan of correction. In addition, there are other administrative due process rights that are afforded enrollees. Should a provider or supplier fail to comply, the consequences include civil monetary penalties, denial of payment or termination.
Proof of Vaccination
Proof of vaccination must be kept in some form by the employer and stored securely and separate and apart from the employee’s personnel file. Examples of acceptable forms of proof of vaccination include:
- CDC COVID-19 vaccination record card (or a legible photo of the card).
- Documentation of vaccination from a health care provider or electronic health record.
- State immunization information system record.
- If vaccinated outside of the U.S., a reasonable equivalent of any of those would suffice.
Employers must establish a process for requesting religious or medical exemption from the vaccine mandate. The CDC has published a document that details the clinical contraindications for a COVID-19 vaccine and the Rule specifically guides employers to that document for reference when setting up the exemption process.
Medical Exemptions: Documentation for medical exemptions must be collected and kept in a secure and separate location by employers. Such documentation should be signed by a licensed medical practitioner who is not the person requesting the exemption and who is acting within the scope of their practice.
Religious Exemptions: Employers are encouraged to review the EEOC manual with regard to religious discrimination when formulating policies for application and approval of religious exemptions. The Safer Federal Workforce Task Force has created a template for that purpose.
The Rule specifically claims to “preempt 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 the Rule. As such, under the express terms of the Rule, any orders by state governors forbidding employers from complying with vaccine mandates are governed by the Supremacy Clause of the Constitution and the specific provision of the Rule and are not effective to insulate affected providers and suppliers from compliance with this Rule.
Reed Smith Commentary
There are several challenges to the successful implementation of this mandate. As an initial matter, we are skeptical that there will be sufficient resources in state survey agencies to implement a prescriptive survey. Some of the identified sites of service are surveyed infrequently by state survey agencies, and the thought of implementing hundreds or thousands of complaint surveys is quite daunting. Secondly, while we don’t know how survey agencies will categorize the severity of this deficiency, we do know that a citation will be followed with the opportunity to cure the deficiency through a plan of correction (given current survey and certification law). Stated otherwise, providers and suppliers who are noncompliant may be able to cure the harm and with only the risk of financial consequences. This risk may vary, however, with the site of service, and we would not be surprised if a skilled nursing facility faced a more severely categorized deficiency, including immediate jeopardy. We will have more insight into this issue when CMS issues interpretive guidance for survey agencies. Finally, it is not impossible that a governor would issue a directive to the state survey agency not to implement this requirement, although such a directive could risk a state’s Federal Financial Participation.
The other issue is the exemption provision. The establishment of an exemption process is delegated to the employer and the employer is empowered to interpret and apply federal guidance when evaluating exemption applications. It is foreseeable that many employees will apply for exemptions and that this process will enact a significant burden on providers and suppliers to evaluate and document decisions with respect to those requests.