McDermott Will & Emery

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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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Marshall E. Jackson, Jr.
Associate
Office: Washington, DC
Year at Firm: 4

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

My favorite part of practicing healthcare law at McDermott is working with clients that are out in front tackling very interesting and unique issues. The healthcare industry continues to evolve, and our clients are at the forefront. The changes in the industry have required clients to navigate areas of uncertainty, and our clients look to us to help them navigate that uncertainty. I have been blessed to sit shoulder to shoulder with a dynamic McDermott team helping our clients tackle new and unprecedented issues. No day is a dull day.

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

Many of our clients face the challenge of balancing the need to deliver affordable, quality healthcare to people when and where they need it, while maximizing return on investment for their business within a hot healthcare market. While one side seems provider-centered and the other investor-centered, providers and investors alike grapple with this balancing act. In addressing this balance in the context of an ever-changing industry, our clients are seizing opportunities to embrace new ways to deliver healthcare, and forming strategic partnerships and collaborations to strike the balance. We are increasingly seeing the industry embrace the use of digital heath technologies to allow providers to reach patients and address growing healthcare concerns. We are also seeing providers, payors, retailers, tech companies, and investors collaborating in new ways to spearhead innovation within the industry. It has been great to work with clients to address this challenge through innovative approaches.

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Healthcare is facing a time of transformation as regulators, providers and other stakeholders take action to improve care coordination and increase the use of technology to deliver care. Hospital and health system innovation centers are increasingly acting as the catalyst to fuel growth and expansion through technology and data. In this episode of the Collaborative…

Name: James A. Cannatti III
Practice Focus Area: Healthcare Fraud & Abuse
Office: Washington, DC
Years at Firm: 1

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

My favorite part of working in the McDermott Health practice, and at the Firm generally, is the team approach to advising clients. Each of us has unique subject matter knowledge and experience in different areas of law. Very often, our clients require advice that cuts across multiple areas and issues. By working together across different disciplines within the Firm and within the Health practice we can provide comprehensive advice and counsel to our clients – not just advice on one discrete issue – and approach things from a broader, strategic perspective to help meet their needs.

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

I work in the healthcare regulatory space, focusing on federal and state fraud and abuse issues. As the healthcare industry has evolved and focused more on delivering value, many fraud and abuse laws, which were written decades ago, have not kept pace and have been seen as barriers to innovation. Over the last few years regulators have signaled a willingness to rethink how some of the laws should be applied to novel arrangements and approaches to care. The evolving regulatory landscape and the potential removal of some of the barriers posed by the fraud and abuse laws presents a significant opportunity for clients to pursue transformative approaches to care within our healthcare system. At the same time, change creates uncertainty and when there’s uncertainty there is also risk. Those who are able to manage the uncertainty and take advantage of new opportunities will be well positioned for success.

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Nora Klein
Associate
Office: Chicago
Years at Firm: 2

What is an interesting fact about yourself that others may not know?

I played college golf at University of Illinois and in September 2019 I will be competing in the United States Women’s Mid-Amateur National Championship in Flagstaff Arizona. This will be the 33rd annually national championship for female golfers over 25 years old. The United States Golf Association runs 16 National Championships a year and to be able to play in one is every golfer’s dream. I feel so grateful to work at a place that quite literally supports me on and off the golf course.

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

The biggest challenge for our clients is also the biggest opportunity – how to grow in the revolutionary and highly profitable yet competitive life sciences industry, which is continuously expanding into new and often groundbreaking subsectors. Navigating these issues makes working at McDermott an enjoyable challenge. We not only need to assist our clients in finding innovative ways to grow their enterprises and remain compliant with healthcare rules and regulations, but also provide thoughtful, forward-looking solutions and plans that allow them to grow as these new subsectors emerge.

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In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development.

Highlights of FDA’s initial proposal included:

  • Focusing on recruiting talent across disciplines;
  • Building multidisciplinary teams for more efficient collaboration;
  • Prioritizing operational excellence through a single and consistent review process;
  • Improving knowledge management through enhancements to information technology and honed expertise within review divisions;
  • Emphasizing safety and risk-benefit analysis before and after approval; and
  • Incorporating the patient voice into product development.

As articulated by former FDA Commissioner Scott Gottlieb, “[a] principal aim of these proposed changes is to elevate the role of . . . scientists and medical officers to take on even more thought leadership in their fields.”  The agency contemplates implementing organizational and structural changes that make drug review divisions more therapeutically-focused to promote efficient review and transparency in – as well as patient and stakeholder access to – the review process. According to the agency, these and other changes that are part of the Cures Act will result in a 20 percent improvement in efficiency.

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Rachel Stauffer
Director, McDermott+Consulting
Focus Area: Health Policy Advocacy and Lobbying
Years at McDermott+Consulting: 1.5

What is your favorite part about your health policy work at McDermott+Consulting? 

We have a deep bench of experts on a wide variety of health policy issues. This allows our team to be involved in so many different aspects of health policy – and that is my favorite part. There is no “normal” or “typical” day here. We work on different types of projects (advocacy, stakeholder engagement, strategic planning, for example) for different clients, including hospital systems, diagnostics, rural health, physician groups and others, in any given day. It keeps me on my toes and gives me an opportunity to learn new things every day.

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

The biggest opportunity and greatest challenge facing clients today is the same: the unsettled health policy landscape. The politics around health policy are not as clear cut as they used to be, even just a few years ago. This puts clients in a unique position to shape and influence policy in ways that were not necessarily available a few years ago. On the other hand, there is little ability to predict what happens next. , It can be challenging to navigate and understand where to focus and how to deliver your message when the politics become murky but, that is what we are here for!

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Drew Elizabeth McCormick
Associate
Office: Boston
Years at Firm: 2

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

I get to work with world class lawyers on cutting edge issues and help our clients navigate the challenges of succeeding in a very dynamic, heavily regulated industry. I am constantly being challenged and learning new things, all while having the honor of helping guide our clients in transforming health care.

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

Definitely the ability to take on risk and succeed in a value-based payment paradigm. We are seeing many shifts in the industry, which are largely being driven by fundamental changes in reimbursement structures away from fee for service. Compounding this, the regulatory framework is lagging behind in many regards, creating tensions and uncertainty that our clients lean on us to help them resolve.

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