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Hospital Price Transparency Rule: Full Steam Ahead
Verrill, November 2020

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should continue to comply with the requirements by the deadline...

What Employers Need to Know About The Families First Coronavirus Response Act - An Animation
Verrill, October 2020

Navigating the ins and outs of the Families First Coronavirus Response Act (FFCRA) can be difficult for employers. This animation seeks to illustrate some of the most important takeaways. Transcript (see animation below): Hi, I'm Tawny, a partner in Verrill's Labor & Employment Practice Group...

Domestic Discovery for Foreign Arbitrations? Now Three Circuits Say “No”
Verrill, September 2020

Well, that didn’t take long! Earlier this month I posted a short piece describing a two-to-two circuit split on the question of whether a foreign private arbitration panel is a “foreign or international tribunal” for purposes of 28 U.S.C. § 1782, which authorizes United States District Courts to require a person who “resides or is found” in the district to provide documents or deposition testimony for use in a proceeding before such a tribunal...

Zoom ADR: Best Practices for Virtually Every Virtual ADR Event
Verrill, September 2020

As the post-COVID-19 “new normal” comes into focus, it is unlikely that civil jury trials will happen in many jurisdictions until at least the spring of 2021. For family law matters, cases involving children or domestic violence will typically take precedence over those that do not. Even in cases involving children, the delays may be significant depending on the backlog of cases that exist from COVID-19 shutdowns...

Domestic Discovery for Foreign Arbitrations? Location, Location, Location!
Verrill, September 2020

International transactions can generate international disputes. A party to a lawsuit in one country may believe that a non-party in another country has information that could be put to good use in the case. Someone being sued in Italy, let’s say, may have engaged the services of an investment banker in New York whose records the other litigant thinks could be used to its advantage in the Italian lawsuit...

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including COVID-19 LDTs
Verrill, August 2020

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory Developed Tests (“LDTs”) and eliminating the requirement for premarket review of LDTs, in the absence of notice-and-comment rulemaking...

PPP Forgiveness Planning Scenarios
Verrill, August 2020

How to use this article: You already know that the Paycheck Protection Program (PPP) is highly complex, with intertwining conditions, exceptions, and definitions that defy simple explanation. This article assumes that you are pretty familiar with PPP terminology as relates to your business. We present nine different scenarios commonly found within the PPP recipient pool and offer an intentionally over-simplified discussion of when and how you should apply for forgiveness...

EU-U.S. Privacy Shield Invalidated: Does Your Company Have a Plan B?
Verrill, July 2020

On Thursday, July 16, 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-U.S. Privacy Shield (“Privacy Shield”) in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18) The CJEU’s ruling voiced concern that the Privacy Shield does not adequately protect EU data subjects’ personal data from U.S...

PPP: How is Maine Faring?
Verrill, June 2020

Originally enacted on March 27, the Paycheck Protection Program (PPP) offers loan support and (potentially) loan forgiveness to qualifying small businesses – generally defined as those with not more than 500 employees. According to the U.S. Census Bureau, just under half of all working Americans are employed by businesses of that size. Protection and maintenance of headcount and wage rates are the key objectives of the PPP program...

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19
Verrill, June 2020

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines key factors and procedures that Institutional Review Boards (“IRBs”) should consider when reviewing such non-emergency requests...

60% Is Not a Cliff, Indeed
Verrill, June 2020

On June 11, the Small Business Administration (SBA) and the Treasury Department published important guidance that the revised 60% condition under the Paycheck Protection Program Flexibility Act will be applied proportionately, and not as a cliff. Background. The CARES Act, enacted on March 27, authorized loans to a wide range of small businesses in an amount equal to 2.5 months of prior year payroll costs (as defined)...

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
Verrill, June 2020

On June 3, 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” with new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. This follows a prior update released by FDA on May 14, 2020, also described below...

FDA Announces Updates to Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
Verrill, June 2020

On June 3, 2020, the US Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency”. The update contains new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. (See guidance here...

Does a Property Insurance Policy Still Provide Coverage if a Business does not Reopen after the COVID-19 Stay At Home Orders are lifted?
Verrill, June 2020

Most property insurance policies in today’s market include a provision that causes coverage to lapse if the property is vacant (as defined by the policy) for a period in excess of 30 days. Fortunately, insurers have generally not enforced this limitation while businesses were under the COVID-19 orders that precluded them from being open to the public. As a result, in most situations, the property policies continued to provide coverage even if the buildings were arguably vacant...

The New PPP Math: 24 + 60 = > Forgiveness + > Paperwork
Verrill, June 2020

On June 5, the President signed into law the Paycheck Protection Program Flexibility Act. This is the second amendment to the Program, the first being to increase funding levels to $659 billion from the original $349 billion. The Flexibility Act dramatically increases the proportion of PPP borrowers who will qualify for 100% forgiveness...

PPP Math for the Self-Employed: And, Yes, There is Still Time
Verrill, May 2020

The Small Business Administration reports that as of May 23 it still had nearly $150 billion of untapped Paycheck Protection Program funds. The Program has been underutilized by self-employed business owners, in part due to complexity. Those micro-businesses, however, make up a significant slice of the U.S. economy and generally would be eligible for PPP funding. This article illustrates potential PPP benefits for a self-employed owner with no employees...

Juggling the Costs of Reopening and Litigation: Try Mediation
Verrill, May 2020

State governments are creating paths to restart their economies. Businesses desperately want to start generating income and put the COVID-19 crisis behind them...

FINALLY!!! . . . SBA Guidance on the Forgiveness Math
Verrill, May 2020

The Punch Line: On Friday, May 15, the Small Business Administration published a new form entitled Loan Forgiveness Application Instructions for Borrowers which, at long last, provides a great deal of guidance on how to calculate loan forgiveness. The Background: Section 1106(b) of the CARES Act famously provides for potential forgiveness in a maximum amount equal to “the sum of [eligible] costs incurred and payments made during the covered [8-week] period...

Should You Adjust Your Plans Based on the New PPP Forgiveness Guidance?
Verrill, May 2020

Your inbox is likely flooded with news about the forgiveness guidance from the Small Business Administration (SBA) that came in the form of instructions on how to fill out the application. These instructions provided much needed guidance and a few unexpected surprises. By now, you might be approaching the half-way point of the eight-week covered period...

The PPP Litigation Wave Is Coming: Anticipated "Qui Tam" Lawsuits Under the False Claims Act
Verrill, May 2020

Many businesses and other borrowers, such as nonprofit organizations, that received Paycheck Protection Program (PPP) loans are now several weeks into disbursing their PPP loans for payroll, mortgage or lease payments, and utility payments. Businesses submitted applications to obtain their PPP loans in which a representative of the business made a number of certifications, including a certification that the loan was “necessary to support ongoing operations...

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...

 

 

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