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Be prepared to act.
That was the consensus from a panel of legal experts who provided an update on the status of federal healthcare, COVID-19 vaccination and testing requirements to Argentum members on Tuesday.
During the virtual presentation, panelists from Foley Hoag and Marsh Senior Care Practice outlined the requirements and legal challenges to rules and standards issued by the Department of Labor’s Occupational Safety and Health Administration and the Centers for Medicare & Medicaid Services.
Regardless of a stay or legal challenges related to the rules, the panelists encouraged providers to prepare by creating applicable policies and procedures and by taking steps to be in compliance if a stay is lifted and / or the courts side in favor of the federal government.
Based on the rules issued and legal implications, the panelists provided a series of recommendations:
- Determine what a covered employer is, and clearly identify which employees are included in the mandate.
- Develop COVID-19 vaccination policies and procedures, and establish a documentation system to verify employee vaccination status.
- Implement a process for exemptions.
- Verify policies for employee time off or paid leave to cover time for vaccination and recovery from side effects.
- Train employees, residents and others on COVID-19 safety policies and procedures.
OSHA healthcare emergency temporary standard
The OSHA healthcare emergency temporary standard went into effect June 21 and applies to healthcare settings where suspected or confirmed individuals with COVID-19 are treated, including assisted living communities, life plan / continuing care retirement communities, nursing homes, skilled nursing facilities, and settings where home healthcare and hospice care are provided.
The standard requires operators to conduct hazard assessments and have written plans to mitigate the spread of the coronavirus. It also requires healthcare employers to provide some employees with N95 respirators and other personal protective equipment. Additionally, it includes social distancing, employee screening, and cleaning and disinfecting protocols.
Stand-alone independent living communities that do not provide COVID-19-related healthcare to residents are not included in the workplace safety rules.
Although the standard is set to expire on or before Dec. 21, it could be changed or become a permanent standard, experts said. To date, there are no legal challenges to the OSHA healthcare emergency temporary standard and it remains in effect, they said.
OSHA COVID-19 emergency temporary standard
The OSHA COVID-19 vaccination and testing emergency temporary standard — effectively on hold after a federal appellate court upheld its stay — is a vaccinate-or-test mandate for private employers with 100 or more employees for which the OSHA healthcare emergency temporary standard does not apply, including stand-alone independent living communities.
All long-term care venues that are required to comply with the healthcare emergency temporary standard are exempt from the vaccination and testing requirements under this standard, which went into effect Nov. 4, the panelists said.
Under the COVID-19 standard, employers must develop, implement and enforce a mandatory vaccination policy or, alternatively, allow unvaccinated employees to undergo weekly COVID testing. Unvaccinated employees also must wear face coverings in the workplace.
Under this standard, employers have until Dec. 6 to develop and implement their policies, and they have until Jan. 4 to implement weekly testing requirements for employees who remain unvaccinated.
Legal challenges to the OSHA COVID-19 standard revolve around arguments that it violates the U.S. Constitution or exceeds OSHA’s statutory authority, or that OSHA did not follow the proper rulemaking process, or that workplace risks do not justify the imposition of the standard, or that OSHA cannot justify a “grave danger” by implementing the emergency temporary standard two years into the pandemic, according to Tara Clayton, senior vice president of Marsh Senior Care Practice.
As of Nov. 12, she said, at least 27 states have challenged the legality of OSHA’s COVID-19 standard. Petitions also have been filed by private litigants and business groups. As of Nov 12, lawsuits and petitions were pending in all but one of the U.S. circuit courts.
Due to the different circuits and multidistrict litigation, the litigation will be consolidated and heard by one circuit court chosen in a lottery. It is anticipated that the case could go to the U.S. Supreme Court for a decision, Clayton said, adding that a decision could take several months to more than a year.
(A federal judicial panel on Tuesday assigned the consolidated caseload to the Court of Appeals for the Sixth Circuit in Cincinnati, according to the New York Times).
CMS emergency regulation
CMS announced its emergency regulation at the same time that OSHA announced its COVID-19 vaccination-and-testing emergency temporary standard. It requires providers and suppliers to impose a vaccination mandate on employees as a condition of participation in the Medicare and Medicaid programs.
Under the CMS interim final rule, staff members must receive a first dose of the COVID-19 vaccine by Dec. 6 or must have requested or been granted an exemption or accommodation. By Jan. 4, all staff members must be fully vaccinated.
Unlike the OSHA COVID-19 rule, the CMS emergency regulation does not offer a testing alternative.
CMS made clear that the rule does not apply to assisted living providers, including that those that participate in Medicaid via home- and community-based services. The rule, however, does apply to skilled nursing facilities and may affect staff members who interact with other employees or residents in skilled nursing facilities, according to Alex Somodevilla of Foley Hoag. The emergency regulation notes that home health agency and hospice workers covered by the regulation often provide services in assisted living communities, and that assisted living residents are at risk of infection because workers in assisted living communities often work in more than one long-term care or healthcare setting where they can be exposed to the coronavirus.
Nov. 10, 10 states filed suit challenging the CMS interim final rule in the U.S. District Court for the Eastern District of Missouri, and on Monday, another 10 states filed suit, led by Alabama.
The primary arguments, Somodevilla said, center on the argument that promulgation of the interim final rule was arbitrary and capricious, that CMS does not have the statutory authority to issue a vaccine rule, that CMS failed to consult with appropriate state agencies, that CMS did not prepare a regulatory impact analysis, and that CMS implemented the rule without notice and a comment period. Somodevilla added, however, that it generally is understood that CMS has broad authority to regulate Medicare / Medicaid-certified facilities.
Because no court, to date, has ruled on those challenges, the rule remains in effect, as do the compliance dates.
Both OSHA and CMS have taken the position that the OSHA COVID-19 vaccination-and-testing emergency temporary standard and the CMS emergency regulation rule preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks or testing, panelists said.
Clayton said that Texas, Oklahoma and Tennessee have conflicting state laws, and Florida is considering legislation that potentially would create a conflict for providers. In those cases, she said, providers should work with their counsel to determine the best way to avoid penalties.