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November 11, 2021

Breaking Down the Biden Administration’s New Vaccine Mandates: How Do they Impact you?

As I’m sure you’ve heard by now, last week, the Biden Administration released two new regulations regarding mandatory COVID-19 vaccinations. First, the Centers for Medicare & Medicaid Services (CMS) issued an Interim Final Reg (IFR) mandating that health care workers at facilities participating in Medicare and Medicaid be fully vaccinated—either two doses of Pfizer or Moderna, or one dose of Johnson & Johnson—by January 4. Second, the Occupational Safety and Health Administration (OSHA) released an Emergency Temporary Standard (ETS) requiring employers with 100 or more employees to ensure each of their workers are fully vaccinated or are tested for COVID-19 on at least a weekly basis by January 4th. OSHA will also require employers to provide paid-time for employees to get vaccinated and ensure all unvaccinated workers wear a face mask in the workplace.

When it comes to new requirements such as these, the devil is in the details, so let me break down these regulations for you by answering some of the top questions I’ve received thus far. I’ll mainly focus on the new CMS IFR, since that directly affects most of you as emergency physicians.

I only work in an urgent care clinic—not in an emergency department within a hospital. Does the CMS IFR apply to me or other staff I work with?

No, it does not. The CMS reg only applies to workers in facilities that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs) or Conditions for Coverage (CfCs). These include hospitals, ambulatory surgical centers, Community Mental Health Centers, Rural Health Clinics/Federally Qualified Health Centers, and other types of facilities. Health care workers who solely work in physician offices and urgent care clinics—as well as emergency medical services (EMS) providers—do NOT have to abide by the new vaccine requirements set forth in CMS’ reg.

I am not employed by a hospital but work either as an independent contractor or as part of a group that contracts with the hospital. Do I have to abide by the new CMS requirements?

Yes, all staff working within the applicable facilities must comply with the vaccine requirements. This includes facility employees, licensed practitioners, students, trainees, volunteers, and any other individuals who provide care to patients under a contract or another type of arrangement. Staff who are full time teleworkers who do not have any contact with patients or other staff are not subject to the requirements.

Are there any exemptions to the new CMS requirements?

Under the CMS reg, all staff within the applicable facilities must receive the first dose of a primary series or a single dose COVID-19 vaccine by December 5, 2021 and must complete the primary vaccination series by January 4th. CMS defines “fully vaccinated” as receiving the primary vaccination series—staff do not need to document that they have received a booster shot.

There are no policies around mandatory testing that would allow staff to circumvent the vaccine mandate. However, there ARE exemptions for staff with recognized medical conditions for which vaccines are contraindicated or for staff who have specific religious beliefs, observances, or practices.

What is the penalty for non-compliance with the CMS IFR?

Hospitals that do not comply with the new CMS vaccine requirements could be terminated from the Medicare program (although CMS would like to avoid those situations).

How do the new CMS requirements relate to the OSHA standards that have been released?

As an emergency physician, the new CMS reg affects you most directly—especially if you deliver care in a hospital emergency department or another type of Medicare or Medicaid-participating facility. However, if you do not work in a facility or are otherwise exempt from the new CMS requirements, it is important to understand the OSHA requirements to see if they apply to you, your group, or the health care setting where you practice.

As you may recall, OSHA had issued an ETS back in June around patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting. While there were some exceptions to these requirements, it did apply to most health care settings, along with EMS providers. In all likelihood, your employer must still abide by these requirements.

Depending on your employment arrangement, your employer also may be subject to the second ETS that OSHA just issued covering employers with more than 100 employees. All in all, CMS states that the agency tried to coordinate with OSHA to ensure that the regulations issued are “complementary” and not “overly duplicative.” However, there are some specific differences between the new OSHA ETS and the CMS requirements—most notably the fact that the OSHA ETS includes an option for unvaccinated workers to be tested weekly instead of getting vaccinated, while the CMS IFR does not include such an option.

I have heard that the OSHA regulation has already been halted by a lawsuit. Will employers still be required to comply with those requirements?

Yes, last weekend, the 5th U.S. Circuit Court of Appeals granted an emergency stay of the new OSHA ETS at the request of attorneys general in Texas, Louisiana, Mississippi, South Carolina and Utah, as well as several companies. The Justice Department responded to the temporary halt earlier this week, and the case is ongoing. In the meantime, the Biden Administration had told businesses to go forward and start working on getting their unvaccinated employees vaccinated. Regardless of the outcome of this OSHA ETS lawsuit (or others that may follow), the CMS IFR has not been challenged yet, so at this point it appears that the requirement that staff within health care facilities be fully vaccinated by January 4th will likely remain in place.

Please let me know if you have any further clarifying questions about the Biden Administration’s new vaccine requirements. Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.

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