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COVID-19 Viewpoints

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As we’ve previously covered, the COVID-19 pandemic has brought about a major increase in the prevalence of telehealth services, due in large part to regulatory flexibilities at the federal and state levels. Beginning in March 2020, state Medicaid programs across the country loosened requirements for coverage of telehealth services provided to Medicaid beneficiaries, reducing barriers by allowing audio-only services and covering a broader scope of services delivered via telehealth. The increase in telehealth has resulted in improved access to behavioral health services in particular, but according to an OIG report issued earlier this week, state Medicaid programs will need to increase their oversight of these services if the telehealth flexibilities become permanent.
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FDA and FTC Coordination Appears to Be Escalating

September 15, 2021 | Blog | By Joanne Hawana

Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the general public. We blogged in 2020 about the increasing use of warning letters jointly issued by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) Division of Advertising Practices in the apparently never-ending fight against fraudulent COVID-19 products (see prior post here). While coordinated FDA and FTC enforcement activities specific to the ongoing public health emergency continue at a brisk pace – as of September 9, 2021, FDA has issued more than 200 warning letters to companies claiming that a product is an effective cure, treatment, or preventative for COVID and the FTC has issued more than 400 pertaining to unsubstantiated health claims for COVID-related products, with many of those being signed by both agencies – these powerhouse regulators also appear to have become more comfortable with announcing joint actions in non-COVID contexts. This trend makes it even more important for manufacturers and marketers of consumer-facing products to be fully aware and compliant with all of their legal and regulatory obligations.
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NY HERO Act Plans ACTIVATED – Employer Action Required

September 9, 2021 | Blog | By Corbin Carter, Michael Arnold

The New York State Commissioner of Health has designated COVID-19 as a “highly contagious communicable disease that presents a serious risk of harm to the public health.” This means that the HERO Act’s many requirements are no longer theoretical: Almost all private New York employers must now activate their HERO Act-compliant workplace exposure prevention plans and take numerous implementation steps required by the recently enacted law. Per the Commissioner’s designation notice, the “activation” designation will remain in effect until at least September 30, 2021, at which point the Commissioner will review the level of transmission of COVID-19 in New York State and determine whether to continue this designation.
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How to Handle Religious Objections to a Workplace Vaccine Mandate

September 2, 2021 | Blog | By Jennifer Rubin

Employers implementing mandatory Covid-19 vaccination programs must manage, and in some cases accommodate, exemption requests. Legal exemptions from mandatory vaccination include medical exemptions under the Americans with Disabilities Act and exemptions based on sincerely held religious beliefs pursuant to Title VII of the Civil Rights Act of 1964 (and equivalent state laws for both federal statutes).
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As previously discussed, many of the telehealth flexibilities in place during the COVID-19 pandemic are set to expire at the end of the federal Public Health Emergency (PHE), unless federal and state legislators act to make the changes permanent. A recent bill introduced by Representative Robin Kelly (D-IL) suggests that Congress is interested in expanding access to telehealth services for Medicare and Medicaid beneficiaries if the benefits of increased access to telehealth can be demonstrated. According to a press release issued by Representative Kelly’s office, “Telehealth has the potential to help equalize healthcare access for underserved populations. However, we need data to understand utilization, cost, fraud, privacy and how to serve those left behind by the digital divide.”
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Bioethics in a Pandemic: Misinformation and Mandates

August 9, 2021 | Blog | By Bridgette Keller, Amy Martin

As the spread of the Delta variant of COVID-19 and the reality of inconsistent vaccine uptake lead to growing case numbers across the country, many of us are wondering, how did we get here and what’s next?
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Throughout the COVID-19 pandemic, information has continuously evolved surrounding the virus and its effects on nearly every aspect of family and public life, particularly on families trying to balance work with remote or in-person learning for their children. In this webinar, two experts from MassGeneral Hospital for Children (MGHfC) discussed current updates surrounding the effectiveness and safety of COVID-19 vaccines for children.
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Masks Off, Masks On - Now What?

July 28, 2021 | Blog | By Jennifer Rubin

CDC’s updated guidance suggesting facial coverings be worn in “public indoor settings” adds a new but hopefully surmountable barrier to returning the workforce to the office (though undefined, we presume this means any indoor location where two or more individuals are working). At the outset, the CDC guidance does not create a Federal workplace mandate but rather provides a baseline for the creation of safety standards grounded in scientific data – data we recognize is not static given the nature of the Coronavirus pandemic. The latest guidance has frustrated some employers who are attempting to develop sensible policies to return their workforce to offices. We offer some practical guidance regarding the changes, if any, employers might consider in response to the latest CDC guidance.
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Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon?

July 13, 2021 | Blog | By Joanne Hawana, Benjamin Zegarelli

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical laboratory testing in general during the COVID-19 public health emergency. We highlighted at the time an August 2020 Trump Administration order barring FDA from requiring premarket review for any LDT unless the agency goes through formal rulemaking procedures. We also speculated that although “the regulatory framework and policies surrounding LDTs will be a prominent topic of debate in 2021…there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future.”
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NY HERO Act Standards & Template Policies Released – Employer Action Required

July 8, 2021 | Blog | By Corbin Carter, Michael Arnold

The New York State Department of Labor (NYSDOL) has released its HERO Act minimum standards and template policies related to airborne infectious disease prevention. Employers now have 30 days after the standards’ publication – until August 5, 2021 – to either: (1) adopt one of the model standard exposure prevention plans applicable to their industry, or (2) develop and establish an alternative prevention plan that meets or exceeds the minimum standards.
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This alert discusses the US State Department’s July 6, 2021 announcement that National Interest Exceptions (NIEs) to the COVID-related travel ban are now valid for 12 months — up from 30 days — and that multiple entries are permitted.
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Return to the Office – Mandatory Vaccinations

June 22, 2021 | Video | By Jennifer Rubin

In this video, Mintz Employment Member, Jen Rubin, discusses a few important issues employers need to know with respect to vaccination programs.
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Return to the Office – Returning to the Basics

June 21, 2021 | Video | By Jennifer Rubin

Whether or not a business has returned fully to a physical workplace, partially with a hybrid arrangement, or has remained remote, there are a few key areas of focus for a successful return. In this video, Mintz Employment Member, Jen Rubin, highlights important issues employers should consider.
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Cal/OSHA has approved revised Emergency Temporary Standards (ETS) and Governor Newsom has issued an executive order waiving the usual 10-day legal review and approval process by the Office of Administrative Law (OAL). This revised ETS (the third version since late May) more closely aligns with the CDC and California Department of Public Health (CDPH) guidelines on face covering restrictions and physical distancing.
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Webinar Recording: Vaccination and the Workplace – Solving for the Latest Challenges Facing Employers

June 17, 2021 | Webinar | By Michael Arnold, Geri Haight, Jennifer Rubin, Corbin Carter

The CDC’s latest guidance lifting many restrictions for most fully vaccinated individuals has forced employers to consider whether and how to implement workplace vaccination policies. During this webinar, our speakers explored the current workplace vaccine compliance landscape and offered best practices for implementing vaccination policies aimed at making workplaces safe and while accounting for jurisdictional, political, philosophical and physical divides.
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Return to the Office – Employer Considerations (Part 1)

June 15, 2021 | Video | By Jennifer Rubin

Now that widespread vaccination appears to be slowing the pandemic, and in light of the CDC’s guidance regarding measures fully vaccinated individuals can take, returning to the office has become a priority for employers across the nation. In this video, Mintz Employment Member, Jen Rubin, discusses some concepts employers should consider as they plan to return employees to the office. 
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ALERT: New York Hits Key 70% Vaccination Metric; Reopening Rules Lifted

June 15, 2021 | Blog | By Corbin Carter, Michael Arnold

It’s been a long road to recovery for employers since New York first issued its NY Forward reopening requirements for offices and other similar environments back in May 2020.  Today, as New York reached a key vaccination metric – 70% of adults have now received at least one vaccine shot – Governor Cuomo announced that New York businesses will no longer be required to abide by the current industry-specific guidelines in order to reopen.  Accordingly, the current NY Forward guidelines on capacity restrictions, social distancing, cleaning and disinfection, health screenings, contact tracing, and other virus-related restrictions are now lifted in most commercial settings. 
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New York Revises COVID-19 Reopening Guidance & HERO Act Changes on the Way

June 10, 2021 | Blog | By Corbin Carter, Michael Arnold

It’s been a busy month (year?) for New York employers – one that has brought several important updates with respect to employers’ reopening plans. On the heels of the State’s May 19th adoption of the recent CDC guidance outlining increased privileges for fully vaccinated individuals, New York State updated its NY Forward COVID-19 reopening guidance on June 8, 2021, including its guidance geared toward office environments. As a reminder, New York businesses opting to reopen during the COVID-19 pandemic must do so consistent with the State’s industry-specific reopening guidelines, found here; affirm their compliance with same prior to reestablishing in-person operations; and implement a written safety plan governing its workplace safety protocols.
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Immigration Viewpoint Thumbnail
This alert covers updated guidance issued by the US Department of State on June 1, 2021 that expands the eligibility for National Interest Exceptions (NIEs) to the travel bans from the Schengen Area of the EU, the U.K., Ireland, China, Iran, Brazil, South Africa, and India.
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Employment, Labor, and Benefits Viewpoints Thumbnail
Cal/OSHA has relaxed some of its COVID-19 Prevention Emergency Temporary Standards (ETS) for fully vaccinated individuals to better align with the California’s June 15, 2021 goal to end most mask and physical distancing requirements. But the proposed revisions stop short of fully adopting the May 13, 2021 CDC guidance for fully vaccinated individuals and do not (yet) provide guidance on several important issues, including the enforcement of documentation for vaccine verification and how employers can demonstrate that physical distancing is not feasible.
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