North America

CMS Vaccination Rule Allowed to Go Forward Nationwide, Though Still Stayed in 24 States

Our colleagues of Epstein Becker Green have a new post on the Health Employment and Labor blog that will be of interest to our readers: “Update: CMS Interim Final Rule Stay Lifted Nationwide, Still in Effect in Twenty-Four Plaintiff States“.

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Holiday Cyber Storm Warnings

Recent data thefts and systems intrusions, particularly with respect to ransomware, have assured that cybersecurity is top of mind for corporate executives and compliance officials. We at EBG have tried to keep you up to date with respect to legislative, regulatory and litigation developments and recommended best practices and procedures. As we close out the year, we all should remain mindful that cyber criminals, especially those who are supported or protected by foreign adversaries, have little incentive to rest up during the holidays. Indeed, they likely will find that a loosened semi-remote business environment offers them opportunities to exploit human and technologic weakness that allow execution of Zero Day exploits and other attacks upon corporate information systems. Through our participation in the National Chamber of Commerce Cyber Security Working Group, we have been actively interfacing with Executive Branch and Congressional officials to contribute to and to monitor the array of proposals being considered by the Congress, and the regulatory guidance being issued by federal agencies including The National Institute of Standards and Technology (“NIST”) of the Department of Commerce, the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency “CISA,” the Department of Health & Human Services Office of Civil Rights that deals with PHI protection, as well as the Treasury Department’s Office of Foreign Asset Control (“OFAC”). Thus, we have issued recent guidance concerning ransomware avoidance and resilience, the availability of helpful best practices tool kits from NIST and CISA, and heightened responsibilities with respect to ransomware payment decisions. We expect that the need for counselling with respect to cybersecurity and privacy compliance, data breach and ransomware response, and litigation defense is unlikely to diminish in the year ahead. From both regulatory and enforcement perspectives, government recognizes it as well.

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Video: Update on Federal COVID-19 Vaccine Rules and NY and NYC Vaccine Mandates – Employment Law This Week

As featured in #WorkforceWednesday This week, we look at the status of the federal government’s COVID-19 vaccine rules for employers and the COVID-19 vaccine mandates in New York State and City.

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CMS Issues Guidance on COVID-19 Testing in the Workplace

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

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Supreme Court Lets New York’s Vaccine Mandate for Health Care Workers Stand

On December 13, 2021, the Supreme Court of the United States rejected the petition of New York health care workers seeking to stop the State from enforcing regulations requiring covered personnel of hospitals, nursing homes, public health centers, and other health care entities to be fully vaccinated against COVID-19 as a condition of continued employment, subject to narrow exceptions. The Supreme Court’s unsigned order allows the continuing enforcement of the regulations, as litigation of the multiple lawsuits challenging the statewide vaccine mandate for health care workers issued last August continues.

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New Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

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A First Arbitration Award in Quebec on Vaccination Against COVID-19 in the Workplace

By Dimka Markova, from our Labour and Employment Law Group

December 15, 2021 — Can an employer, a service provider, require proof of vaccination from its employees when its customer requires that all persons accessing its establishment be adequately vaccinated against COVID-19? What happens to employees who are not vaccinated and are denied access to the workplace by that customer? Arbitrator Denis Nadeau seems to have been the first to have to address these contemporary issues in an arbitration award rendered on November 15: Union des employés et employées de service, section locale 800, et Services ménagers Roy ltée (grief syndical), 2021 QCTA 570.

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Florida Issues Notice of Emergency Rule and Guidance on New Vaccination Exemption Law

Governor Ron DeSantis recently signed HB 1-B, Ch. 2021-272, Laws of Fla. (the “Vaccination Exemption Law”), which prohibits every private employer from issuing COVID-19 vaccination mandates for its Florida employees without allowing employees to opt out for five specific exemptions: (i) medical reasons, including pregnancy or expectation of pregnancy, as determined by a physician, advanced practice registered nurse, or physician assistant; (ii) religious reasons, based on a sincerely held belief; (iii) COVID-19 immunity, based on prior COVID-19 infection, as documented by a lab test; (iv) periodic testing, agreed to by the employee and at no cost to the employee; or (v) based on compliant use of employer-provided personal protective equipment (“PPE”), agreed to by the employee.  Employers that receive a “completed exemption statement” must allow the requesting employee to “opt out” of the employer’s vaccination requirements.[1]  Employers will be found to have violated the Vaccination Exemption Law by failing to provide for exemptions in their COVID-19 vaccination mandate and terminating the employee—which includes “the functional equivalent of termination,” as defined below.

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New York Governor Reinstates Mask Mandate

Today, New York Governor Kathy Hochul announced a new mask mandate for private businesses that do not require proof of vaccination for entry, which will take effect Monday, December 13, 2021 and remain in place through January 15, 2022.  The announcement is part of the State’s effort to combat the “winter surge” from the COVID-19 pandemic, along with the spread of the Omicron variant.

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Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 1) – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.

Attorneys Helaine FingoldLesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.

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