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Bioethics in a Pandemic: Learning from the Past

September 1, 2020 | Blog | By Bridgette Keller, David Friedman

As we continue to discuss the ethical considerations related to the distribution of a safe and effective coronavirus vaccine, it is important to consider lessons learned from other pandemics. Though the particular facts of past pandemics of course differ from those of COVID-19, the goal of public health has always been to promote and protect the health and well-being of a population. Similarly, the ethical distribution of resources amid any pandemic is supported by the balance and tension among the four ethics principles: autonomy, justice, beneficence, and nonmaleficence. Here, we look at lessens learned from the poliovirus, ebolavirus, and 2009 H1N1 pandemics, as well as the National Pandemic Strategy related to vaccine distribution.
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Earlier today, the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released preliminary guidelines on the allocation of initial and limited supplies of a forthcoming COVID-19 vaccine. Once finalized, this framework will inform how policymakers and health professionals should initially prioritize vaccine recipients, taking into account factors such as mitigating community spread, maximizing public health benefits, and ensuring equitable vaccine access for underserved communities.

Though the turnaround time is short, there are two ways for interested stakeholders and member of the public to submit feedback regarding the draft plan:
1. Speak at TOMORROW’s Public Listening Session (September 2, 12 PM EDT). Speakers must adhere to a strict 5-minute time limit and submit their interest in speaking in advance.
2. Submit Written Comment by September 4 at 11:59 PM EDT. Comments and uploaded materials will be made available in the Committee’s Public Access File and should be submitted at this link.
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Bioethics in a Pandemic: The Basics

August 26, 2020 | Blog | By Bridgette Keller, David Friedman

Before we continue our Bioethics in a Pandemic series, we thought it would be helpful to provide a quick overview of the various principles that inform ethical decision-making in the health care setting.

As you might imagine, providing health care to individuals with diverse background and values presents ethical choices for health care professionals every day, throughout the entire health care system – providers, administrators, policymakers, insurers, employers, and even the health care lawyers! Well-recognized bioethics scholars Tom Beauchamp and James Childress offer a principle-based approach to guide ethical decision-making in health care. The four principles are (1) Respect for Autonomy, (2) Nonmaleficence, (3) Beneficence, and (4) Justice.
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NASAA’s COVID-19 Task Force Uncovers Investment Scams Related to the Pandemic

August 26, 2020 | Blog | By David L. Ward, Jason Burrell

In response to the COVID-19 pandemic, the North America Securities Administrators Association (NASAA) put together a task force in April 2020 specifically targeted to use “online investigative techniques to identify websites and social media posts that may be offering or promoting fraudulent offerings, investment frauds, or improper unregistered regulated activities” which were related to any aspect of COVID-19.
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The landscape for foreclosures and evictions in New York State is constantly evolving. With the entire State of New York in Phase 4 of New York Forward, the courts have begun to reopen (at least virtually) and certain foreclosure proceedings have resumed. Eviction proceedings remain stayed as against those commercial and residential tenants who demonstrate COVID-related hardship.
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As we discussed in our previous blog post, the Department of Health and Human Services’ Office for Civil Rights (OCR) released guidance this past June to address how health care providers could contact, in a HIPAA-compliant manner, recovered COVID-19 patients to provide them with information about donating blood and plasma to potentially help other COVID-19 patients. On August 24, OCR released an updated version of that guidance to address similar communications from health plans. The amended guidance provides that health plans may also reach out to recovered COVID-19 patients about blood and plasma donation, subject to the same restrictions applicable to health care providers.
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This article summarizes the most recent pandemic-era proposals for wind, solar, and carbon capture federal tax incentives and attempts to discern potential trends for the future.
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Bioethics in a Pandemic: Vaccine Distribution

August 19, 2020 | Blog | By Bridgette Keller, David Friedman

After months of stay-at-home orders, quarantine protocols, social distancing, and back-to-school planning, the ever- present question on everyone’s mind is, When will we get back to business as usual?  For many, the answer involves discussion of a safe and effective vaccine, including when it will be available and who will be able to get it. Even though a vaccine likely won’t be available until 2021 at the earliest, experts are already thinking about how to distribute it.  This post is the first in a blog series that will consider the various bioethics issues and principles related to the COVID-19 pandemic.
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Recent DOJ Comments Shed Light on Expected Civil Enforcement of COVID-19 Cases

August 18, 2020 | Blog | By Nicole Henry, Karen Lovitch

Comments made by Department of Justice attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys expect that civil enforcement related to COVID-19 relief funds will focus on certifications made by applicants seeking loan forgiveness and anticipate increased investigations into telemedicine services.
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SEC Risk Alert Addresses COVID-19 Compliance Risks and Considerations

August 14, 2020 | Blog | By David L. Ward, Jason Burrell

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Employment, Labor, and Benefits Viewpoints Thumbnail
A New York federal judge recently struck down certain aspects of the U.S. Department of Labor’s (“DOL”) Final Rule and accompanying guidance interpreting leave entitlements under the Families First Coronavirus Response Act (“FFCRA”). This decision increases the number of employees eligible for COVID-19-related leave, and will require employers to revisit their leave administration policies and procedures. However, it’s is unclear at this time whether New York will request the Court impose a nationwide injunction or injunctive relief that extends only to New York employers.
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Return to Work COVID-19 Testing Considerations

August 10, 2020 | Blog | By Danielle Bereznay, Michael Arnold, Corbin Carter

As employees increasingly transition back into the physical workplace, employers have begun to grapple with whether and how to deploy COVID-19 diagnostic testing as a return-to-work solution. Many employers want to avoid extended employee quarantine or isolation requirements that prevent their employees from returning to the office for weeks and disrupt their operations. But is this potential solution legal? And is it effective? Below we discuss practical considerations for employers considering a return to work COVID-19 testing strategy.
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On August 4, CMS posted a proposed rule on CY 2021 Payment Policies, which included important updates about the expansion of Medicare covered telehealth services due to the COVID-19 pandemic. Here, we cover this and other important developments related to telehealth access during the pandemic and beyond.
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United States Attorney Andrew E. Lelling recently announced that the U.S. Attorney’s Office for the District of Massachusetts entered into a Memorandum of Understanding with Special Inspector General Brian D. Miller of the Office of the Special Inspector General for Pandemic Recovery to investigate and prosecute fraud in the distribution of the funds authorized by the Coronavirus Aid, Relief, and Economic Security.
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Massachusetts Legislature Negotiating Extending the 2019-2020 Session Beyond July 31st

July 30, 2020 | Blog | By Steven Baddour, Daniel Connelly, Kaitlyn Sprague, Taylor Shepherd

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363 Sales as a Health Care M&A Tool, Part 1 – Overview

July 28, 2020 | Blog | By Deborah Daccord, William Kannel, Rachel Irving Pitts, Tim McKeon, David Chorney

Although health care may be well positioned to weather an economic downturn as an industry, certain sectors, including ambulatory surgery, vision, dermatology, dental, and other physician practices will bear the brunt of COVID-19 stay-at-home orders and patients delaying non-emergency care. While the onset of COVID-19 has delayed or derailed many transactions, strategic buyers should consider all of the different transaction tools available them to help maximize value and successfully get to closing. For knowledgeable investors and strategic buyers, now is the time to position yourself to acquire valuable health care assets at steep discounts.

For those unfamiliar with 363 Sales, a 363 Sale couples a flexible and fast process with ample liability protection for willing buyers. The primary benefit to a 363 Sale is that a buyer can acquire the debtor’s assets free and clear of virtually all liens, claims and encumbrances burdening the assets and the debtor. When a target is experiencing severe financial distress, the benefit of acquiring assets “free and clear of all liens” is extraordinarily valuable.
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The Future of Telehealth

July 24, 2020 | Video | By Sarah Beth Kuyers

Sarah Beth Kuyers discusses the actions taken at the federal and state level to increase access to telehealth in response to the COVID-19 pandemic and takes a look at the recent movement to make some of these changes permanent.  
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Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.
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