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FDA Updates its Guidance on Conducting Clinical Trials During COVID-19 Public Health Emergency
Verrill, April 2020

On April 16, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” adding seven new questions and answers to the guidance’s appendix. To learn more about the FDA’s guidance, please see our prior alerts here and here...

OHRP Issues Guidance on the Conduct of Research During COVID-19 Public Health Emergency
Verrill, April 2020

The U.S. Department of Health & Human Services Office for Human Research Protections (“OHRP”) issued guidance, dated April 8, 2020, on the application of Common Rule requirements to research being conducted during the COVID-19 public health emergency...

What Commercial Landlords Need to Know About Massachusetts Moratorium on Evictions and Foreclosures
Verrill, April 2020

On April 20, Massachusetts enacted a moratorium on evictions and foreclosures during the COVID-19 emergency (House, No. 4647). While the Act addresses residential tenants and residential foreclosures as well as commercial tenants, this brief synopsis is limited to the impact of the Act on commercial tenants and their landlords. Massachusetts courts are essentially prohibited from entertaining any non-essential eviction action with respect to a small business premises unit...

Webinar Materials: When a Crisis Strikes: Effective Business Planning and Communications
Verrill, April 2020

With a health and economic crisis underway, the in house legal team is a crucial part of a company's response team. Whether facing the COVID-19 pandemic or an employment-related claim and subsequent investigation, your business and communications strategies need to work together from the start. This webinar kicks off with an overview of the top ten things in house counsel need to know to best deal with internal investigations...

PPP Loan Forgiveness: Further Guidance on the Math
Verrill, April 2020

NOTE: You may have seen Verrill’s earlier introduction to the complexities of Paycheck Protection Program math. The article below provides an even deeper look into the loan forgiveness portion of that math. Thousands of companies have submitted applications for loans under the Paycheck Protection Program (PPP), and those funds are beginning to hit bank accounts across the country...

Executive Order Temporarily Modifies Requirements for In-Person Notarization and Acknowledgement in Maine
Verrill, April 2020

On April 8, 2020, Maine Governor Janet Mills signed an Executive Order titled “An Order Temporarily Modifying Certain In-Person Notarization and Acknowledgement Requirements.” The purpose of this Order is to enable citizens to execute critical estate planning, real estate, business, litigation and other documents in a manner that reduces in-person contact, and that in ordinary times are required to be executed in person before a notary public and/or witnesses under Maine law...

PPP Forgivable Loan Program: How to Do the Math
Verrill, April 2020

(Originally published 4/2/2020, revised 4/3/2020) Thousands of articles are circulating about the new Paycheck Protection Program under the CARES Act signed into law on March 27. Having a general idea about how this Program works is good. But if you have questions about the math, then this article is for you. The following is a slightly simplified explanation of how to compute the loan amount and the forgivable amount...

Should Health Care Employers Prepare for COVID-19 As A Work-Related Injury?
Verrill, April 2020

While we know that everyone is being bombarded with COVID-19 recommendations, advice, news, and data, another important issue to manage in the workplace is the possibility of COVID-19 infection, if acquired at work and due to the work performed, resulting in a workers’ compensation injury. Generally, in order for an injury or illness to be work-related, the condition must both “arise out of” and “in the course of” employment...

Massachusetts COVID-19 Essential Services as they Relate to the Construction Industry
Verrill, April 2020

On March 23, 2020, Governor Baker issued “an emergency order requiring all businesses and organizations that do not provide ‘COVID-19 Essential Services’ to close their physical workplaces and facilities to workers, customers and the public as of Tuesday, March 24, 2020. These businesses are encouraged to continue operations remotely.” On March 31, 2020 the Governor extended and modified the order...

Updated FDA COVID-19 Guidance for Conduct of Clinical Trials
Verrill, April 2020

On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding a series of questions and answers (“Q&A”)...

Congress Passes the Paycheck Protection Program
Verrill, March 2020

On March 27, the United States Congress passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES” Act). The Act contains many provisions affecting broad swaths of the U.S. economy. The purpose of this memo is to summarize the Act’s provisions regarding forgiveness of SBA loans used by business to cover payroll, rent, and other expenses necessary for the continued operation of their businesses otherwise known as the “Paycheck Protection Program...

U.S. Department of Labor Publishes Q&A Guidance on Families First Coronavirus Response Act
Verrill, March 2020

On March 24, 2020, the U.S. Department of Labor (DOL) released an initial set of questions and answers (Q&As) concerning the recently enacted Families First Coronavirus Response Act (FFCRA). This is the first round of DOL guidance providing information to employees and employers about how each will be able to take advantage of the protections and relief offered by the FFCRA when it takes effect on April 1, 2020. DOL is expected to publish a workplace poster later today...

COVID-19: Resources for Our Valued Family Law Clients
Verrill, March 2020

This is an unprecedented time in our history, calling for an equally unprecedented level of collaboration among families, especially those who struggle with conflict. We wanted to share with you some facts about how we are dealing with the current pandemic and its effect on our clients and their families, as well as offer you some resources to help you and your family navigate the difficult waters ahead...

IRS News Release Describes Plan to Implement Families First Coronavirus Response Act
Verrill, March 2020

On Friday, March 20, 2020, the Internal Revenue Service (IRS) issued a News Release, IR 2020-57 (Release), that describes the new paid leave benefits for certain employees of small and medium-sized businesses under the Families First Coronavirus Response Act (Act). In addition, the Release explains how employers will be subsidized by the federal government through payroll tax credits and reimbursements...

A Healthy Approach to Possible Commercial Lease Defaults in the Age of Coronavirus (COVID-19)
Verrill, March 2020

As COVID-19 cases mount across the country, the inability to perform commercial lease obligations due to unforeseen circumstances has moved to the forefront. In contract-speak, unforeseen circumstances that lead to non-performance by a party are known as “force majeure” events...

Is the Coronavirus Pandemic a Force Majeure?
Verrill, March 2020

The coronavirus disease pandemic is an ongoing shock to the U.S. economic system and every-day life. The construction industry is on the front line of the tumult. Earlier this week, Boston Mayor Marty Walsh ordered the stoppage of construction projects within the City of Boston. The City of Cambridge has now followed suit...

Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services
Verrill, March 2020

In the past few days, in an effort to help keep Medicare beneficiaries healthy during the COVID-19 pandemic, key federal agencies within the U.S. Department of Health and Human Services (“HHS”) and the U.S. Department of Justice, Drug Enforcement Administration (“DEA”), announced they were relaxing certain requirements that relate to the provision of telehealth services to Medicare beneficiaries and other patients...

COVID-19: FDA Clinical Trial Guidance
Verrill, March 2020

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic. In the guidance, FDA outlines important considerations for assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity...

Employer Obligations under the Revised Families First Coronavirus Response Act (H.R. 6201)
Verrill, March 2020

On March 18, 2020, President Trump signed into law the Families First Coronavirus Response Act (the “Act”) in response to COVID-19. Among other provisions, the Act gives a broad group of employees the right to emergency paid sick leave and also expands protections under the Family and Medical Leave Act (“FMLA”). This summary focuses on the impact to most private employers from the paid sick leave and expanded FMLA provisions, which take effect on April 2, 2020...

Congress Passes Emergency Paid Leave Laws in Response to Coronavirus Pandemic
Verrill, March 2020

On March 18, Congress passed and the President signed into law the Families First Coronavirus Response Act, a temporary measure designed to increase the availability of paid leave during a time when many employees are being directed to stay at home...

COVID-19 Expanded Access Template
Verrill, March 2020

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug...

To Test or Not to Test: Employer Considerations Amid COVID-19 Pandemic
Verrill, March 2020

Q: I am concerned about employees coming to work with a fever—can I test employees’ temperatures before allowing them to work to avoid spreading the coronavirus? Verrill’s View: Maybe—but there are many factors to consider. Generally, taking an employee’s temperature would be a restricted medical examination, but employers may have more flexibility due to COVID-19’s “pandemic” status...

High-Deductible Health Plans can Cover Coronavirus Costs
Verrill, March 2020

Recognizing the need to eliminate potential administrative and financial barriers to testing for and treatment of the 2019 Novel Coronavirus (COVID-19), in Notice 2020-15, posted today on IRS.gov, the IRS advised that high-deductible health plans (HDHPs) can pay for COVID-19-related testing and treatment, without jeopardizing their status. This also means that an individual with an HDHP that covers these costs may continue to contribute to a health savings account (HSA)...

Should Employers Recognize COVID-19 As A Work-Related Injury?
Verrill, March 2020

While we know that everyone is being bombarded with COVID-19 recommendations, advice, news and data, one area that appears to have been overlooked is the question of whether COVID-19 infection, if acquired at work and due to the work performed, might result in a workers’ compensation injury. That specific question has not yet been litigated, but the best answer this writer can provide is “probably, yes”...

Leave Sharing Programs: A Critical Bridge for Employees Affected by COVID-19
Verrill, March 2020

  The federal government may soon be providing paid leave assistance to employees affected by COVID-19. In the meantime, however, employers that maintain leave sharing programs can leverage those programs to help soften the financial impact on employees forced to miss work because of COVID-19. Leave sharing programs allow employees to donate their accrued paid time off for use by other employees affected by a medical emergency or major disaster...

 

 

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