Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting products, services, facilities and distribution channels to aid in the pandemic response. Simultaneously, they must maintain shareholder value, navigate highly complex regulatory hurdles and compliance obligations while rethinking strategies for growth in a post-COVID-19 world. McDermott Will & Emery and EY co-hosted a webinar to discuss critical COVID-19-related operational, regulatory and legal developments. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording. 

  1. FDA enforcement discretion is a flexible, risk-based approach, not a free pass. Companies operating under FDA’s enforcement policies to provide COVID-19 countermeasures should have a strategy to ensure that products comply with the standard applicable requirements if the products will still be in distribution after the public health emergency ends. FDA will prioritize areas for follow-up and review after this crisis; clear documentation and protocols describing deviations from standard FDA procedures or requirements will be important in a post-COVID-19 environment.
  2. Clinical trials remain an important FDA priority, and COVID-19 presents an opportunity to transform the clinical development model. The agency has been very flexible in terms of the approaches it is taking to allow trials to continue, including through the use of technology, such as remote patient monitoring, video consent and telemedicine, as well as the use of home health. Such innovations may break down traditional barriers in clinical trials and make them simpler, faster and more patient-friendly. Despite the flexibility, launching new trials and enrolling and monitoring patients will remain a challenge.
  3. Pivot toward COVID-19 responses and changes to prescription demand will disrupt life sciences supply chains for months to come. Companies will need to ramp up manufacturing and put new distribution channels in place to meet demand. This will need to be done despite a limited and constrained workforce. There may be delays in foreign and domestic inspections and potentially delays in products coming to market.
  4. Antitrust compliance remains an important priority, particularly as competitors have begun collaborating to address supply chain issues. While regulators and companies have been engaged in finding creative solutions to supply chain challenges, the pandemic does not offer carte blanche to engage in anti-competitive activity. Companies should consider proactively engaging with the government where possible with respect to partnerships. When not possible, they should  review DOJ and FTC guidance to mitigate enforcement risk down the road.
  5. Life sciences companies with international footprints can take advantage of government assistance programs from more than one country. US companies with operations in Europe and European companies with US subsidiaries can take advantage of government assistance programs in the countries in which they operate, depending on corporate structure and asset locations.
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In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent

Nicholas Alarif
Office: Washington, DC
Years at Firm:  3

What is your favorite part about practicing healthcare law at McDermott? 

I hate to sound like a broken record, but the best part about practicing at McDermott is the innovative and collaborative culture. I have found that McDermott fosters a team-based approach to solving client issues. The opportunity to interact with experts in so many disciplines and sub-disciplines to achieve common goals for our clients has been fantastic. Further, I have found that my colleagues are open to new approaches to tackle client issues and are always happy to streamline internal processes. Innovation is not what you typically think of in a law firm environment, and McDermott’s embrace of change makes for an exciting and fun place to practice.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

The biggest opportunity and greatest challenge may actually be the same—a shifting regulatory landscape. For instance, the Centers for Medicare and Medicaid Services and the Office of Inspector General recently published proposed revisions to the physician self-referral law (Stark Law) and the Anti-Kickback Statute (AKS) regulations, which, among other things, are attempting to foster transitions from fee-for-service medicine to value-based care. These proposed changes will potentially allow providers broader flexibility when engaging in financial relationships with a value-based goal. The proposed changes present the industry with many new opportunities to participate in novel compensation arrangements with providers.  However, these proposed changes come with a degree of uncertainty regarding what is in and out of bounds. That is to say, what type of value-based arrangements will squarely satisfy a Stark Law exception or AKS safe-harbor and which arrangements may subject a provider to material compliance risks? These types of questions often emerge with a shifting regulatory paradigm, and dually offer stakeholders with both risk and reward.

What kind of client work gets you most excited when it comes across your desk?


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Matt Perreault
Office: Boston
Years at Firm:  2

What is your favorite part about practicing health care law at McDermott? 

As so many of my colleagues have expressed throughout this series, my favorite part of practicing healthcare law at McDermott is being a member of a collaborative and collegial team that is advising our diverse clients on their most critical and pressing issues.  Having spent much of my career in-house, I have experienced firsthand how McDermott’s approach to client service, anchored in humility, empathy and practicality, consistently delivers differentiated value and results for our clients.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

I believe that the transition to value-based arrangements will continue to accelerate. Collaborative Transformations will proliferate and present both tremendous opportunities for, and challenges to, traditional healthcare providers. Hospitals, health systems and other providers who embrace the challenges and opportunities presented by this paradigm shift will reap the benefits of their investments.  Those who resist this cultural change risk losing ground and market share to their competitors.

What kind of client work gets you most excited when it comes across your desk? 


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Hospitals and health systems are facing consumer demand for innovation, the need to expand and enhance streams of revenue and the push for improved quality, all while navigating changing regulations, federal enforcement, antitrust litigation and business pressures. 2019 saw hospitals and health systems navigate these challenges and more, with valuable lessons for 2020.

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Joe Parise
Partner
Office: Boston
Years at Firm: 6

What is your favorite part about practicing healthcare law at McDermott? 

In short: the people. I have always had a cross-office practice, and as a result have been lucky enough to work with many different attorneys within the Health practice group. I am constantly impressed by the depth and breadth of experience that the group offers, as well as the creativity and thoughtful approach that our attorneys bring to tricky client issues. Being surrounded by talented attorneys (from the senior partner to the junior associate ranks) makes me want to “raise my game” and, I think, brings out the best in each of us.

In addition to the professional qualities, I am grateful for the fact that our attorneys bring a positive attitude each and every day, and create an enjoyable working environment. I have made some great personal connections over the years, and consider many of my colleagues to be good friends.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

For the most part, I work with healthcare services providers and those that invest in such providers. I think the biggest opportunity for my clients relates to innovation in healthcare services delivery. Embracing new technologies (including those related to telehealth), optimizing the collection and use of data – these are the tools that will allow providers to improve outcomes and reduce costs of care.

From my perspective, the biggest challenge for healthcare provider clients (and those clients that invest in the healthcare services industry) will be continuing to manage the transition to value-based care. The cost of healthcare in the US has been, and will continue to be, a hot topic for political and economic discussion. The movement away from traditional fee-for-service reimbursement, and towards a model that is based on value and outcomes, is one about which all providers must be thinking carefully.

What kind of client work gets you most excited when it comes across your desk?


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Larry Guess
Partner
Office: Chicago
Years at the Firm: 6 years

What is your favorite part about practicing healthcare law at McDermott? 

My favorite part of practicing healthcare law at McDermott is the complexity of our client matters and working with my colleagues to get great results for our clients. The healthcare industry is constantly changing and innovating, and our clients engage us to help them adapt to these changes and maximize innovation in the space.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today? 

The biggest opportunity facing our clients is the bullish investment perspective in the healthcare industry. Currently, there are buyers with a tremendous amount of capital to deploy and sellers looking to maximize current market conditions. The healthcare transactional climate is very dynamic and certain clients are willing to invest in more risky assets. While the payoff can be substantial, the speed and complexity of these transactions can be very challenging for clients.  McDermott’s healthcare group excels in delivering value to our clients by managing the speed of transactions while navigating complex regulatory regimes, enabling our clients to understand the risk associated with a particular investment and opportunities to maximize returns.

What kind of client work gets you most excited when it comes across your desk? 


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Jeremy Earl
Partner
Office: Washington, DC
Years at the Firm: 10

What is your favorite part about practicing healthcare law at McDermott?

My favorite part about practicing at McDermott is the challenging and constantly evolving nature of the work. Our clients put trust in us to advise them on their toughest legal questions and business challenges. I don’t take that trust lightly and it is exciting to come to work every day to meet and exceed the high expectations clients rightly have for us.

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?

I represent managed care companies, which has traditionally meant health insurers and health maintenance organizations (HMOs). Due to legislative and competitive factors, healthcare financing and delivery is rapidly evolving and new models are being introduced to compete with traditional health insurers and HMOs. In 2012, Ezekiel Emanuel and Jeffrey Liebman boldly predicted in the New York Times that “[b]y 2020, the American health insurance industry will be extinct” and replaced by ACOs. That this has not happened is, at least in part, due to innovation by health insurers through such efforts as expanding value-based payment models.

At the same time, the traditional roles of providers and health insurers are blurring and providers and risk-bearing intermediaries are introducing innovative ways to finance healthcare delivery that compete with health insurers. While this has increased competitive pressures on managed care companies, I am excited to support companies who are driving this innovation.

What kind of client work gets you most excited when it comes across your desk?
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