CMS interim rule on vaccinations supersedes state or local orders

by A.J. Plunkett (aplunkett@decisionhealth.com)

The new CMS interim final rule that requires staff vaccinations against COVID-19 supersedes state or local laws or orders that prevent vaccine mandates, notes Marge McFarlane, PhD, MT(ASCP), CHFM, CHSP, CJCP, HEM, MEP, with Superior Performance Consultants in LaPointe, Wisconsin.

But the CMS rule may not cover all healthcare entities.

As you move to implement the requirements of CMS Omnibus COVID-19 Health Care Staff Vaccination interim final rule (IFR) announced November 4, 2021, be aware that physician offices do not need to comply with the IFR, says McFarlane.

However, physician offices may need to comply with OSHA’s vaccination mandate for offices with 100 or more employees, she says.

In addition, physician offices may need to comply with the OSHA COVID-19 emergency temporary standard (ETS) issued in June 2021. “These are complimentary programs,” says McFarlane.

The OSHA ETS on vaccines was also announced on November 4. Both the CMS and OSHA rules were scheduled to be published in the Federal Register November 5, 2021.

The CMS IFR applies to individuals working in Medicare- and Medicaid-participating facilities, as well as individuals working in other settings involving face-to-face interactions with patients, says McFarlane. 

The IFR requires all clinical and non-clinical personnel to have received at least the first dose of a COVID-19 vaccine by December 5, 2021, and complete the vaccine course by January 4, 2022.

“There are guidelines for medical and religious exemptions but testing in lieu of vaccination is not an option,” warns McFarlane. “Those entities that are required to comply with the IFR are not required to comply with the OSHA COVID-19 Vaccination and Testing ETS also released on November 4, 2021.”

All suppliers and contractors (including construction) that enter the CMS participating health care entities, which include hospital, critical access, end stage renal, home health, hospice, and other facilities receiving Medicare or Medicaid funds, must be vaccinated.  

“This federal law by CMS overrules any state or local mandate that prevents mandatory vaccination,” McFarlane noted, pointing to section 5 of the rule which begins on page 163.

That section, labeled “Federalism,” notes that “Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule would pre-empt some State laws that prohibit employers from requiring their employees to be vaccinated for COVID-19.”

“Consistent with the Executive Order, we find that State and local laws that forbid employers in the State or locality from imposing vaccine requirements on employees directly conflict with this exercise of our statutory health and safety authority to require vaccinations for staff of the providers and suppliers subject to this rule. Similarly, to the extent that State-run facilities that receive Medicare and Medicaid funding are prohibited by State or local law from imposing vaccine mandates on their employees, there is direct conflict between the provisions of this rule (requiring such mandates) and the State or local law (forbidding them),” according to the rule.

“As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader grounds for exemptions than provided for by Federal law and are inconsistent with this IFC. In these cases, consistent with the Supremacy Clause of the Constitution, the agency intends that this rule preempts State and local laws to the extent the State and local laws conflict with this rule.”

The section goes on to note that CMS has considered other alternatives, such as relying entirely on voluntary vaccination, source control, and social distancing “and has concluded that the mandate established by this rule is the minimum regulatory action necessary to achieve the objectives of the statute,” says the rule.

The OSHA ETS announced Thursday requires vaccination and testing at private employers with greater than or equal to 100 employees firm or corporate wide.

“The 100-plus employees do not need to be located in the same place,” notes McFarlane. “This ETS also covers states with OSHA approved state plans that cover state and local government employees plus the 100-plus private employers.”

“Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to elect either to get vaccinated or to undergo regular COVID-19 testing and wear a face covering at work. The employer must record the vaccination status of all employees.”

The ETS do not apply to employees who do not report to a workplace where other individuals are present; employees while working from home; or employees who work exclusively outdoors. 

For more on the CMS rule and how it may be enforced, see this article on the Accreditation & Quality Compliance Center.