Certain Health Care Providers May Be Subject to New COVID Vaccination Requirements

November 8, 2021

Updated with additional clarifying information following the Supreme Court ruling on January 13, 2022.

An interim final rule (IFR) [PDF] issued by the Centers for Medicare & Medicaid Services (CMS) will require select health care providers that receive Medicare and/or Medicaid reimbursement to vaccinate all staff against COVID-19 by January 4, 2022. A separate IFR [PDF], which has implications for all employers (health care and non-health care alike) with more than 100 employees, was issued by the Occupational Safety and Health Administration (OSHA). The OSHA rule requires vaccination or testing of employees. The federal policies create a foundation for COVID-19 requirements; state and local laws may vary when providing more prescriptive guidance such as 100% vaccination requirements for certain professionals. Individuals must follow the most stringent requirements that apply.

CMS and OSHA will accept comments on the IFR through January 4, 2022.

Numerous lawsuits were filed on Friday, November 5, against the OSHA IFR. On Saturday, the U.S. Court of Appeals for the Fifth Circuit suspended implementation of the IFR until it is assessed in greater depth.

On Thursday January 13, 2022, the U.S. Supreme Court blocked enforcement of the OSHA rule requiring vaccination or testing of employees for employers with over 100 employees. The Administration has not indicated whether they will continue to pursue a vaccination requirement for employers under OSHA.

Vaccination Requirements for Health Care Providers Receiving Medicare and/or Medicaid Reimbursement

Applicability

(updated 1/13/22)

The Supreme Court upheld the vaccination requirements for select health care providers, but the compliance deadline may be adjusted. The IFR's vaccine requirements apply to the following categories of Medicare CMS regulated facility types:

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)
- The regulation applies only to Medicare defined clinics and rehabilitation agencies subject to related conditions of participation as facilities; not just groups or individuals in a private practice arrangement.
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)

Clinicians working in private practices, group practices, and in other non-facility settings with fewer than 100 employees are not subject to either IFR. School-based providers are also explicitly exempt as CMS does not regulate schools.

In the rule and associated educational resources (see question: Do the new COVID-19 staff vaccination requirements apply to my therapy practice? [PDF]), CMS stated that they used their authority to regulate health care facilities and that clinicians, such as audiologists and speech-language pathologists, working in settings not subject to facility related CMS Conditions of Participation, Conditions of Coverage, or Requirements are exempt from the HHS IFR.

Requirements for covered entities:

All new or existing staff who interact directly with patients or with other staff who interact with patients must comply with the requirements of the IFR. Staff includes, but is not limited to, facility employees, licensed practitioners, students, trainees, volunteers, and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or another arrangement.
The vaccination requirements do not apply to staff who telework 100% of the time or only provide services via telehealth remotely. Health care providers should also ensure compliance with all state and local requirements that may be more prescriptive.
All staff subject to the vaccine requirement must receive the single Janssen (Johnson & Johnson) or first dose of the Pfizer or Moderna vaccines by February 14, 2022. For those requiring a second mRNA vaccine, the second dose must be received by March 15, 2022. (updated 1/18/22)
Medical and religious exemptions from the vaccine requirement must be established by the covered health care entity (e.g., the hospital or SNF). CMS recommends medical exemptions be based on the Centers for Disease Control and Prevention (CDC) guidance [PDF]. CMS suggests religious or moral exemptions be developed based on guidance from the Equal Opportunity Employment Commission (EEOC) (primarily, but not exclusively, found in Sections K and L). Audiologists of SLPs who believe their exemption request was inappropriately denied may also contact the EEOC for assistance.
Federal regulations preempt any state laws that prohibit vaccine requirements. However, CMS expects the health care provider to comply with any more stringent state requirement.

Health care providers who are subject to these requirements must develop and maintain written policies, including exemption processes, and must maintain records demonstrating compliance with the vaccine requirements. The health care provider must maintain records of vaccination status such as a copy or picture of the staff member’s vaccination card. Documentation of medical exemptions should include:

all information specifying why the COVID-19 vaccines are clinically contraindicated for the staff member,
the signature of the licensed physician or practitioner who has determined that the vaccine is contraindicated, and
a statement by the authenticating physician or practitioner who recommended the staff member be exempted.

For employees who are granted a religious or medical exemption, the health care provider must establish policies for additional precautions such as, but not limited to, testing, physical distancing, and remote work options. CMS requires covered facilities to ensure that act to minimize the risk of transmitting COVID-19.

CMS will use a state survey agency process to monitor compliance and may implement civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreements depending on the level of noncompliance.

Vaccine and Testing Requirements for Employers with 100 or More Employees

(updated 1/13/22)

The U.S. Supreme Court blocked implementation of this rule on January 13, 2022.

OSHA issued an emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100+ employees) from the risk of contracting COVID-19. However, this rule will not go into effect after the U.S. Supreme Court blocked its implementation.

The rule originally required covered employers to strongly encourage vaccination and develop, implement, and enforce a mandatory COVID-19 vaccination policy or adopt a policy requiring employees to either get vaccinated or wear a face covering at work and undergo regular COVID-19 testing. This was intended as a temporary rule known as an ETS (emergency temporary standard).

The rule was meant to go into effect on November 5, 2021, and gave employers until December 5, 2021, to meet all requirements except testing for unvaccinated employees. Employers were to implement the testing requirements for all employees who had not yet completed the entire primary dose(s) of a COVID-19 vaccine by January 4, 2022. This testing rule would not have applied to any settings where the CMS Vaccination rule applies; the CMS rule would have superseded the OSHA rule for as long as the CMS rule remains in effect.

Employers who have already developed a vaccination policy that is at least as prescriptive as the requirements outlined in the OSHA rule would not have needed to develop or implement a new policy.

Requirements for covered entities:

Create a policy detailing how the employer will meet all ETS requirements and ensure it is available for examination by employees in an accessible manner.
The policy must include information on an exemptions process for medical and religious exemptions along with policies on protecting those who remain unvaccinated.
Obtain evidence of employee vaccination status or exemptions and maintain a roster of vaccinated and unvaccinated staff. The employee roster marking those who have obtained their primary vaccines must include information on employee’s primary vaccination status, employers do not need to take inventory of booster shots or additional doses. Fully vaccinated is defined as obtaining full immunity from the manufacturer’s primary vaccine dose (J&J requires a single dose, Pfizer and Moderna require two doses – full vaccination is reached two weeks after the final primary shot).
Support staff in obtaining vaccination dose(s) including up to 4 hours paid time off (PTO) to access the shot and reasonable time and paid sick leave for any side effects. Employers are not required to offer PTO for employees who are already vaccinated or received their vaccine outside of work hours.
Require regular COVID-19 testing for employees who have not completed their primary vaccination dose(s). The Frequency of testing should be based on how often the employee comes into the workplace. Employers are not required to pay for the cost of testing under this ETS. *Note that other state and federal laws may have additional requirements.
Plan how to manage a positive test result including notifying all staff of exposure and promptly removing the individual who tested positive from the workplace until they meet the employer’s criteria to return.
Ensure any employee who has not completed their primary vaccine dose(s) wears a face covering when indoors or in a vehicle with another person present.
Report all COVID-19 fatalities to OSHA within 8 hours and all inpatient hospitalizations within 24 hours after the employer is notified.
Employees who do not come into a workplace and work remotely or outdoors 100% of the time are not subject to vaccination, masking, or testing requirements.

Showing evidence of a previous COVID-19 infection would not have replaced the vaccination or masking and testing requirements under this rule. OSHA indicates that there is not enough scientific or statistical evidence to show that a COVID infection would lead to the same sustained immunity as a full primary vaccination.

OSHA offers a short summary [PDF], FAQs, and a fact sheet [PDF] on the ETS for COVID Vaccination and Testing. Employers with less than 100 employees are not subject to this rule but are encouraged to adopt similar policies. However, this temporary rule was challenged in court and blocked by the U.S. Supreme Court.