On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited vaccine distribution and expanded testing.
The PHE declaration follows the recent appointment of federal officials to head up the monkeypox response team, including Robert Fenton of the Federal Emergency Management Agency as White House national monkeypox response coordinator, and Dr. Demetre Daskalakis of the US Centers for Disease Control and Prevention as White House national monkeypox response deputy coordinator.
The administration also began holding what will be a recurring weekly briefing with congressional staff on August 4. A press release from the US Department of Health and Human Services (HHS) on the PHE declaration can be found here.
Many employers will likely encourage vaccination rather than mandate it. In this Ladders article, McDermott Partner Michelle Strowhiro notes the administrative burdens associated with tracking mandatory employee vaccination.
US employers have grown increasingly interested in identifying incentives that increase COVID-19 vaccination among employees. The US Departments of Labor, Treasury and Human and Human Services recently issued guidance regarding the application of the Health Insurance Portability and Accountability Act (HIPPA) wellness rules to vaccine-related premium surcharges and discounts, clarifying that employers may charge vaccine premium incentives if they adhere to the requirements of activity-only health-contingent programs. In this Employee Benefit Plan Review article, McDermott Partner Judith Wethall and McDermott Associate Sarah G. Raaii outline what this HIPPA guidance means for employers.
The US Supreme Court’s January ruling allowing the Centers for Medicare & Medicaid Services to enforce its COVID-19 mandate is likely to continue to face challenges. Nevertheless, in this article published by the Health Care Compliance Association, McDermott Partner Sandra DiVarco said that the Supreme Court’s decision wasn’t a surprise.
“Many of [the CMS] providers may have slow-walked their compliance and now in theory need to be fully compliant,” DiVarco noted.
On January 13, 2022, the Supreme Court of the United States released two emergency opinions that change the landscape of the three federal vaccine rules. In summary:
A 5-4 Court majority let the Centers for Medicare & Medicaid Services (CMS) enforce its vaccine mandate nationwide, impacting specified healthcare facilities.
A 6-3 majority blocked the US Occupational Safety and Health Administration (OSHA) from enforcing its vax-or-test Emergency Temporary Standard (ETS) applicable to large employers.
The third federal vaccine rule—the federal contractor vaccine mandate—remains subject to multiple legal challenges and, at this time, the government is blocked from enforcing the mandate nationwide. The Court has not yet weighed in on this mandate.
A flurry of litigation in federal district and appellate courts has led to an even split between states in which the COVID-19 vaccine mandate issued by the US Centers for Medicare and Medicaid Services (CMS) may be implemented and states in which such implementation has been prevented. Additional appeals are expected shortly; however, the practical effect of these decisions on enforcement of the CMS mandate remains uncertain.
On December 7, 2021, the US District Court for the Southern District of Georgia issued a nationwide injunction that blocks the federal government from enforcing the federal contractor and subcontractor vaccine mandate. The preliminary injunction issued is for the pendency of the litigation challenging the enforceability of the mandate filed by the states of Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. This injunction order may be challenged on appeal.
On November 16, 2021, 12 states—Montana, Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Oklahoma, South Carolina, Utah and West Virginia—filed a complaint in the US District Court for the Western District of Louisiana requesting that the Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered healthcare facilities and staff be declared arbitrary and capricious, contrary to law and in excess of the Centers for Medicare and Medicaid Services’ (CMS) statutory authority. CMS published an IFR on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for healthcare facilities. The expansive IFR applies to more than a dozen types of healthcare providers and suppliers (facilities), affects more than 10 million healthcare staff and carries an anticipated potential price tag in excess of $1.3 billion dollars for the first year of implementation.
Even though the US Court of Appeals for the Fifth Circuit temporarily blocked the Occupational Safety and Health Administration’s (OSHA) COVID-19 vaccination rule for employers (though not for the healthcare sector), businesses should continue preparing for important OSHA deadlines.
According to this Reuters article, workplace whistleblowers and fears of disappearing federal funds will likely help with vaccination mandates within businesses, hospitals and nursing homes. However, OSHA is unlikely to demand proof from every healthcare provider of vaccination and testing protocols. The Centers for Medicare & Medicaid Services (CMS) also typically does not survey accredited healthcare providers unless there is a complaint or a need for recertification, McDermott Partner Sandra DiVarco noted.
“On a stakeholder call, CMS reiterated their desire to work with providers to come into compliance and not to sort of send SWAT teams to go out and look for problems,” DiVarco said.
On October 4, 2021, the US Departments of Labor, Treasury, and Health and Human Services issued guidance regarding the application of the Health Insurance Portability and Accountability Act (HIPAA) wellness rules to vaccine-related premium surcharges and discounts, clarifying that employers may charge vaccine premium incentives if they adhere to the requirements of activity-only health-contingent programs.
Employers have grown more interested in exploring incentives designed to increase COVID-19 vaccination rates among employees. Some employers have announced plans to charge unvaccinated employees higher contributions for health coverage than vaccinated employees, while some have been considering other options, such as excluding coverage for COVID-related illnesses, charging higher cost-sharing for COVID-19-related illnesses and offering more generous plan options to employees who are vaccinated.
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