Overview

On September 9, the Biden administration announced a new COVID-19 Action Plan, titled “The Path Out of the Pandemic.” The plan takes a six-pronged approach to combat COVID-19, which includes advancing COVID-19 mitigation and response efforts through vaccination and masking, keeping schools safely open and bolstering our economic recovery.

The first portion of this six-part plan outlines efforts to reduce the number of unvaccinated Americans through regulatory powers and authorities. To enact this goal the President took the following actions:

• Signed two new Executive Orders that would require vaccinations for all federal workers and contractors. The Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees requires all Federal executive branch workers to be vaccinated in accordance with guidance to be issued by the Safer Federal Workforce Task Force (the “Task Force”), established by Executive Order No. 13991. This Executive Order builds upon previous vaccination requirements made in July for federal employees, by taking away the option for routine testing with limited exceptions. The Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors requires vaccinations for all employees working on or in connection with covered federal government contracts and subcontracts, with limited exceptions.
   
• Instructed the Department of Labor’s Occupational Safety and Health Administration (OSHA) to develop a rule requiring employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis. OSHA released an emergency temporary standard (ETS) in response to this request on November 5, 2021, however the ETS was ultimately blocked by the U.S. Supreme Court on January 13, 2022.
   
• Instructed the Centers for Medicare and Medicaid Services (CMS) to develop a rule requiring workers in health care settings that receive Medicare and Medicaid reimbursements to implement vaccination and testing protocols. This regulation would be released as an Interim Final Rule, and would be an extension of CMS’s impending rule that would require vaccination for nursing home employees announced last month.  

Below is a brief FAQ that provides an overview of common questions and answers regarding the each of the new regulations and guidance, and their potential impact on counties. 

CMS Interim Final Rule

Executive Summary

On November 4, the U.S. Centers for Medicare & Medicaid Services (CMS) released an interim final rule (IFR) outlining COVID-19 vaccination requirements for eligible staff at health care facilities participating in Medicare and Medicaid programs. Health care workers in these facilities will need to be fully vaccinated by January 4, 2022 to provide care, treatment, or health care services.

Frequently Asked Questions

1. What type of facilities does this rule apply to?

The IFR applies to providers and facilities who are regulated under the CMS Conditions of Participation. These facilities include:

• Ambulatory surgical centers
• Hospices
• Programs of all-inclusive care for the elderly
• Hospitals
• Long-term care facilities
• Psychiatric residential treatment facilities
• Intermediate care facilities for individuals with intellectual disabilities
• Home health agencies
• Comprehensive outpatient rehabilitation facilities
• Critical Access Hospitals
• Clinics
• Community mental health centers
• Home infusion therapy suppliers
• Rural Health Clinics/ Federally Qualified Health Centers and end-stage renal disease facilities

Facilities excluded from this requirement include:

• Assisted living facilities
• Group homes
• Home and Community Based Services (HCBS)
• Religious nonmedical health care institutions
• Organ procurement organizations
• Portable x-ray suppliers
• And physician’s offices

2. What are the basic requirements under this rule?

Eligible facilities and providers are mandated to meet the following requirements under the IFR:

1. Develop a process/plan for vaccinating all eligible staff
2. Develop a process/ plan for providing exemptions and accommodations for those who are exempt
3. Develop a process/plan for tracking and documenting staff vaccinations

3. Which employees does the rule apply to?

These requirements apply to all eligible staff – both current and new – working in the facility, regardless of their clinical responsibility or patient contact.

4. How does CMS define fully vaccinated?

CMS defines fully vaccinated as two or more weeks since the completion of a primary vaccination series for COVID-19 (one single-dose vaccine or the completion of a two-dose vaccine). Of note- the requirement does not apply to booster doses.

5. Are exemptions allowable under the rule and if so, what are the conditions for which an employee can file an exemption?

There is no testing option for unvaccinated staff under this requirement. However, the regulation also allows exemptions centered on medical conditions for which vaccines are contraindicated or religious beliefs, observances, or practices.

The basics for medical exemptions include:

1. Facilities must develop a process for permitting staff to request a medical exemption
2. Facilities must ensure all documentation is signed and dated by a licensed practitioner
3. Documentation must contain all information specifying why the COVID-19 vaccines are clinically contraindicated for the staff member
4. Documentation must include a statement by the authenticating practitioner recommending the staff member be exempted

The basics for religious exemptions include:

1. Facilities must develop a process for permitting staff to request a religious exemption
2. Facilities must ensure all requests for religious exemptions are documented and evaluated in accordance with applicable federal law and as a part of the facility’s policies and procedures

6. What type of accommodations can be made for employees that are exempt?

CMS requires facilities to develop a process for implementing additional precautions for any staff who are not vaccinated. Potential accommodations for exempted staff could include, but are not limited to:

• Testing
• Physical Distancing
• Source Control

In all cases – facilities must ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals

7. Are there any new data reporting requirements associated with this rule?

There are no new data reporting requirements within this regulation. However facilities, specifically hospitals and nursing homes, are still expected to continue complying with previously set data reporting requirements in emergency regulations issued by CMS in May 2020, August 2020 and May 2021 respectively.

8. What are the compliance deadlines?

Facilities and providers will need to create a policy to determine if eligible staff have taken the first step to meet COVID-19 vaccine guidelines by the first compliance deadline of receiving the first dose by December 5, 2021. Further, all eligible staff will need to be fully vaccinated by January 4, 2022, to provide care, treatment, or other health care services.

9. How will the rule be enforced?

CMS will work directly with State Survey Agencies to ensure health care settings are meeting the three requirements mentioned above. Facilities and providers out of compliance will be cited and provided an opportunity to return to compliance before enforcement remedies such as civil monetary penalties, denial of payment and termination from the Medicare and Medicaid program are employed.

10. How will this rule interact with other regulations and requirements?

If your facility participates in the Medicare and Medicaid programs and is regulated under the CMS Conditions of Participation, Conditions for Coverage, or Requirements, then the CMS IFR takes priority, and your facility is expected to abide by the requirements.

If facilities are not certified under the Medicare and Medicaid programs and therefore not regulated by the CoPs, then the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or OSHA COVID-19 Healthcare Emergency Temporary Standard apply.

If none of the above regulations apply, then employers are subject to the OSHA Employer Emergency Temporary Standard (for facilities with greater than 100 employees

This regulation pre-empts any state law under the Supremacy Clause of the United States Constitution.

11. Is there a public comment period for the rule?

The requirements were posted in the Federal Register as an Interim Final Rule (IFR) with a 60-day public comment period, with requirements within the rule effective immediately.

Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees

1. Which county employees would be covered by this mandate?

According to the Safer Federal Workforce Task Force’s guidance that was released on September 24, a “covered contractor employee” is any full-time or part-time employee of a covered contractor working on or in connection with a covered contract or working at a covered contractor workplace. This includes employees of covered contractors who are not themselves working on or in connection with a covered contract.

2. Are counties that have received federal funding from the cares act and the American rescue plan considered government contractors, and thus subject to the executive order signed by the president on September 9?

No. Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, applies to federal contractors and subcontractors who enter into “any new contract; new contract-like instrument; new solicitation for a contract or contract-like instrument; extension or renewal of an existing contract or contract-like instrument; and exercise of an option on an existing contract or contract-like instrument.”

The Executive Order specifically states that it shall not apply to:

• Grants;
• Contracts, contract-like instruments, or agreements with Indian Tribes under the Indian Self-Determination and Education Assistance Act;
• Contracts or subcontracts whose value is equal or less than the simplified acquisition threshold, as that term is defined in section 2.101 of the Federal Acquisition Regulation;
• Employees who perform work outside the United States or its outlying areas, as those terms are defined in section 2.101 of the Federal Acquisition Regulation; or
• Subcontracts solely for the provision of products

3. What is considered a covered contract or contract-like instrument?

For the purposes of determining which employers are covered under Executive Order 14042, the term “contract or contract-like instrument” shall have the meaning set forth in the Department of Labor’s proposed rule, “Increasing the Minimum Wage for Federal Contractors, ” 86 Fed. Reg. 38816, 38887 (July 22, 2021).