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The Massachusetts Supreme Judicial Court Clarifies the Contours of the Attorney-Client Privilege and Work Product Doctrine in Internal Investigations
Verrill, April 2021

In Attorney General v. Facebook, Inc., No. SJC-12496 (March 24, 2021),[i] the Massachusetts Supreme Judicial Court clarified the scope of protection afforded by the attorney-client privilege and the work product doctrine to internal investigations. At issue was the Massachusetts Attorney General’s request to obtain documents Facebook collected and created during its expansive internal investigation in the wake of the 2018 Cambridge Analytica scandal...

Employers Required to Give Free COBRA Coverage to be Offset by Medicare Tax Credits
Verrill, April 2021

Among other things, the American Rescue Plan Act of 2021 (“ARPA”), signed into law on March 11, 2021, provides “assistance eligible individuals” (“AEIs”) who lose their health insurance coverage under an employer’s group health plan due to: (1) an involuntary termination of employment (other than for gross misconduct), or (2) a reduction of hours (both events referred to here as an “ARPA qualifying event”), will be eligible for a 100%

Domestic Discovery for Foreign Arbitrations? – Now It’s the Supreme Court’s Turn
Verrill, March 2021

In two earlier posts, I described the Circuit split over the question of whether a foreign private arbitration panel is a “foreign or international tribunal” for purposes of 28 U.S.C. § 1782...

New Reporting and Penalties for Small Business Owners
Verrill, March 2021

In the United States of America, what do a small restaurant owner, a real estate developer who wants to keep properties separate, a mom-and-pop store with fewer than 20 employees and a drug cartel shell company all have in common? Under a new federal law, they all will need to report the individual ownership of their businesses to the government or face stiff penalties...

Massachusetts Health Care Bill Makes Several Significant Changes
Verrill, January 2021

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s months of work to address various health care delivery system and social equity issues that the COVID-19 epidemic has hastened...

Finding Teeth in Massachusetts' Prompt Payment Act
Verrill, January 2021

In Tocci v. IRIV Partners, LLC, Boston Harbor Industrial Development LLC and Hudson Insurance Co. (November 19, 2020, Sup. Ct. 19-405), the Massachusetts Superior Court granted summary judgment on a contractor’s breach of contract claim based on Massachusetts’ Prompt Payment Act, M. G. L. c. 149 § 29E (the “Prompt Pay Act” or “Act”)...

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?
Verrill, January 2021

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) published a final rule revising regulations to the Stark Law. The Stark Final Rule adds, modifies and clarifies key definitions and exceptions...

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies
Verrill, January 2021

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered outpatient drugs purchased by providers at 340B discounted rates to contract pharmacies, so that contract pharmacies can dispense such drugs to patients on behalf of providers. See HHS General Counsel Advisory Opinion, dated December 30, 2020...

Employee Benefits & Executive Compensation 2020 Year-End Client Advisory
Verrill, December 2020

Click here to view as a PDF. This Client Advisory highlights important developments in the law governing employee benefit plans over the past year. It offers insight into what these developments mean for employers and plan sponsors and previews developments we expect to see in 2021...

340B Providers Get Partial Relief from New Dispute Resolution Regulation
Verrill, December 2020

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers participating in the 340B Program. 85 Federal Register 80632 (Dec. 14, 2020), available at https://www.govinfo.gov/content/pkg/FR-2020-12-14/pdf/2020-27440.pdf (“ADR Rule”)...

“If I've Told You Once, I've Told You Eight Times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Over
Verrill, November 2020

Each year, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues dozens of audit reports. While each is important in its own way, some stand out with language that appears to reflect OIG’s fraying patience and may lay the groundwork for possible future enforcement action. A report issued on November 16, 2020, falls into this category...

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...

 

 

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